The following data is part of a premarket notification filed by Les Laboratorires Brothier, S.a. with the FDA for Algoderm Alginate Wound Dressing.
| Device ID | K905314 |
| 510k Number | K905314 |
| Device Name: | ALGODERM ALGINATE WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| 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 | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-28 |
| Decision Date | 1991-02-19 |