fda 510k mask | Surgical Masks - Premarket Notification [510(k)] …

Keyword	CPC	PCC	Volume	Score	Length of keyword
fda 510k mask	0.93	0.7	7391	53	13
fda	1.79	0.5	738	47	3
510k	0.27	0.4	6870	47	4
mask	0.02	0.1	6349	54	4

Keyword	CPC	PCC	Volume	Score
fda 510k mask	0.61	0.1	1602	88

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Surgical Masks - Premarket Notification [510(k)] …
fda.gov

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/surgical-masks-premarket-notification-510k-submissions

In the table below, FDA has identified the risks to health generally associated with the use of the surgical masks addressed in this document. The information we recommend you include in your 510(k) to address these identified risks are given in this guidance document, as shown in the table below. We recommend that you c… FDA has developed this guidance document to assist industry in preparing premarket notification submissions for surgical masks and other masks including isolation masks, procedure masks, and dental masks. These devices may be used by healthcare personnel during procedures to p…

In the table below, FDA has identified the risks to health generally associated with the use of the surgical masks addressed in this document. The information we recommend you include in your 510(k) to address these identified risks are given in this guidance document, as shown in the table below. We recommend that you c…
FDA has developed this guidance document to assist industry in preparing premarket notification submissions for surgical masks and other masks including isolation masks, procedure masks, and dental masks. These devices may be used by healthcare personnel during procedures to p…

DA: 73 PA: 61 MOZ Rank: 77

510(k) Clearances | FDA
fda.gov

https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances

Aug 31, 2021 · Section 510 (k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is...

DA: 34 PA: 11 MOZ Rank: 50

Premarket Notification [510(k)] Submissions - Food …
fda.gov

https://www.fda.gov/files/medical%20devices/published/Guidance-for-Industry-and-FDA-Staff--Surgical-Masks---Premarket-Notification-[510(k)]-Submissions--Guidance-for-Industry-and-FDA-(PDF-Version).pdf

Surgical Masks - Premarket Notification [510(k)] Submissions . Document issued on: March 5, 2004 and a correction posted on July 14, 2004. The draft of … File Size: 285KB Page Count: 17

File Size: 285KB
Page Count: 17

DA: 7 PA: 34 MOZ Rank: 95

510(k) Premarket Notification - Food and Drug Administration
fda.gov

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122717

510(k) Number: K122717: Device Name: FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK: Applicant: TIGER MEDICAL PRODUCTS LTD: 1 HUAIHAI ZHONG ROAD: LIU LIN TOWER, SUITE 1910: SHANGHAI, CN 200021 Applicant Contact: DAVID WANG: Correspondent: TIGER MEDICAL PRODUCTS LTD ...

DA: 31 PA: 70 MOZ Rank: 6

510(k) Premarket Notification - Food and Drug Administration
fda.gov

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K965043

mask, surgical: 510(k) Number: K965043: Device Name: 3M 1830 FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK AND 3M 1830FS FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK WITH FACE SHIE: Applicant: MINNESOTA MINING AND MFG. CO. 3M CENTER: st. paul, MN 55144 -1000 Applicant Contact: karen c maass:

DA: 74 PA: 23 MOZ Rank: 74

510(k) Premarket Notification - Food and Drug Administration
fda.gov

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K182766

surgical mask with antimicrobial/antiviral agent: 510(k) Number: K182766: Device Name: Cufitec Surgical Mask: Applicant: NBC Meshtec Inc. 2-50-3 Toyoda: hino, JP 191-0053 Applicant Contact: tomokazu nagao: Correspondent: Globizz Corporation: 1411 W. 190th St. Suite 200:

DA: 83 PA: 41 MOZ Rank: 53

510(k) Premarket Notification - Food and Drug Administration
fda.gov

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K190308

510 (k) Number. K190308. Device Name. Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Leve. …

DA: 100 PA: 11 MOZ Rank: 50

Premarket Notification 510(k) | FDA - U.S. Food and Drug …
fda.gov

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k

A 510 (k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a … mask

mask

DA: 40 PA: 42 MOZ Rank: 90

Air Queen Offers 510K FDA Approved N95 Equivalent …
ortoday.com

https://ortoday.com/air-queen-offers-510k-fda-approved-n95-equivalent-mask-in-u-s/

Jun 25, 2020 · The Air Queen mask is a FDA 510k approved surgical respirator (K172500) with a use indication as follows, “to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganism, body fluids and particulate materials .”

DA: 74 PA: 37 MOZ Rank: 47

May 2021 510(K) Clearances | FDA
fda.gov

https://www.fda.gov/medical-devices/510k-clearances/may-2021-510k-clearances

Jun 08, 2021 · 510 (K) SUMMARIES OR 510 (K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD May 2021 DEVICE: Neuro-IOM system with Neuro-IOM.NET software Neurosoft Ltd 510 (k) NO: K190703 (Traditional ...

DA: 62 PA: 4 MOZ Rank: 90