K021889 is an FDA 510(k) clearance for the SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.). This device is classified as a Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (Class II - Special Controls, product code KKY).
Submitted by Surgical Technology Laboratories, Inc. (Cleveland, US). The FDA issued a Cleared decision on October 16, 2002, 131 days after receiving the submission on June 7, 2002.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3500.
| 510(k) Number | K021889 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2002 |
| Decision Date | October 16, 2002 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KKY — Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3500 |