The following data is part of a premarket notification filed by Derma-safe Co. with the FDA for Surgical Prep Razor.
Device ID | K874370 |
510k Number | K874370 |
Device Name: | SURGICAL PREP RAZOR |
Classification | Razor, Surgical |
Applicant | DERMA-SAFE CO. 32 JUNIPER RD. Wayne, NJ 07470 |
Contact | Warren J Grosjean |
Correspondent | Warren J Grosjean DERMA-SAFE CO. 32 JUNIPER RD. Wayne, NJ 07470 |
Product Code | LWK |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-26 |
Decision Date | 1987-11-13 |