K894478 is an FDA 510(k) clearance for the UHMWPE SURGICAL MESH. This device is classified as a Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (Class II - Special Controls, product code KKY).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 8, 1990, 233 days after receiving the submission on July 18, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3500.
| 510(k) Number | K894478 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 1989 |
| Decision Date | March 08, 1990 |
| Days to Decision | 233 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KKY — Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3500 |