The following data is part of a premarket notification filed by Les Laboratorires Brothier, S.a. with the FDA for Wound Dressing.
Device ID | K922540 |
510k Number | K922540 |
Device Name: | WOUND DRESSING |
Classification | Bandage, Liquid |
Applicant | LES LABORATORIRES BROTHIER, S.A. 7527 WESTMORELAND AVE. St Louis, MO 63105 |
Contact | Evan Dick |
Correspondent | Evan Dick LES LABORATORIRES BROTHIER, S.A. 7527 WESTMORELAND AVE. St Louis, MO 63105 |
Product Code | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-29 |
Decision Date | 1992-08-24 |