K071470 is an FDA 510(k) clearance for the IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX. This device is classified as a Mesh, Surgical, Polymeric (Class II - Special Controls, product code FTL).
Submitted by Implantech Associates, Inc. (Ventura, US). The FDA issued a Cleared decision on August 31, 2007, 94 days after receiving the submission on May 29, 2007.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K071470 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2007 |
| Decision Date | August 31, 2007 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FTL - Mesh, Surgical, Polymeric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |