Submission Details
| 510(k) Number | K905314 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 28, 1990 |
| Decision Date | February 19, 1991 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
K905314 is an FDA 510(k) clearance for the ALGODERM ALGINATE WOUND DRESSING, a Dressing, Wound, Drug, submitted by Les Laboratorires Brothier, S.A. (St Louis, US). The FDA issued a Cleared decision on February 19, 1991, 83 days after receiving the submission on November 28, 1990. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K905314 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 28, 1990 |
| Decision Date | February 19, 1991 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |