K000487 is an FDA 510(k) clearance for the MEDTRADE PRODUCTS ALGINATE ISLAND. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Medtrade Products , Ltd. (Crewe, GB). The FDA issued a Cleared decision on April 18, 2000, 64 days after receiving the submission on February 14, 2000.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K000487 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2000 |
| Decision Date | April 18, 2000 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KGN — Wound Dressing With Animal-derived Material(s) |
| Device Class | — |