The following data is part of a premarket notification filed by G.d. Searle And Co. with the FDA for Swr Disposable Prep Razor.
Device ID | K810112 |
510k Number | K810112 |
Device Name: | SWR DISPOSABLE PREP RAZOR |
Classification | Instrument, Surgical, Disposable |
Applicant | G.D. SEARLE AND CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KDC |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-16 |
Decision Date | 1981-02-04 |