J & J Dip Water Additive

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K821693 ↗

FDA Product Code

FYH

Device Class

Class I

Regulation

21 CFR Part 878.3910

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• P.F.C. Uni-Compartmental Knee System

  Class II

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• J & J Cardiovascular Maxima Hollow Fiber Oxygenato

  Class II

  FDA 510(k) K853251 Active Cleared 16 Oct 1985

• Darwin Knee System (TC3)

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  FDA 510(k) K952830 Active Cleared 18 Jan 1996

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  FDA 510(k) K871295 Active Cleared 29 May 1987

• Coman(R) Cu-11 Model Number 82-6634

  Class II

  FDA 510(k) K945585 Active Cleared 26 Oct 1995

• Fotofill Activator Light

  Class II

  FDA 510(k) K772278 Active Cleared 3 Jan 1978

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