The following data is part of a premarket notification filed by Les Laboratorires Brothier, S.a. with the FDA for Adhesive Bandages & Pads For Minor Cuts/scrapes.
| Device ID | K893123 |
| 510k Number | K893123 |
| Device Name: | ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES |
| Classification | Dressing, Wound, Drug |
| Applicant | LES LABORATORIRES BROTHIER, S.A. BIOMETRIC RESEARCH INSTITUTE 1401 WILSON BLVD., SUITE 400 Arlington, VA 22209 |
| Contact | Frank L Hurley |
| Correspondent | Frank L Hurley LES LABORATORIRES BROTHIER, S.A. BIOMETRIC RESEARCH INSTITUTE 1401 WILSON BLVD., SUITE 400 Arlington, VA 22209 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-25 |
| Decision Date | 1990-02-13 |