K063178 is an FDA 510(k) clearance for the BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106. This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).
Submitted by C.R. Bard, Inc. (Canston, US). The FDA issued a Cleared decision on November 21, 2006, 33 days after receiving the submission on October 19, 2006.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K063178 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 2006 |
| Decision Date | November 21, 2006 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTM — Mesh, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |