Content of a 510(k) | FDA
https://www.fda.gov/medical-devices/premarket-notification-510k/content-510k
Prepareeither a 510(k) Summary or a 510(k) Statement. The Summary or Statement is required for all 510(k)s whether the device is Class I, II, or III. A 510(k) Summary is a summary of information upon which you based your claim of substantial equivalence. The 510(k) Statement is a certification that the 510(k) ownerwill providesafety and effectivene...
Prepareeither a 510(k) Summary or a 510(k) Statement. The Summary or Statement is required for all 510(k)s whether the device is Class I, II, or III. A 510(k) Summary is a summary of information upon which you based your claim of substantial equivalence. The 510(k) Statement is a certification that the 510(k) ownerwill providesafety and effectivene...
DA: 23 PA: 66 MOZ Rank: 35