K962824 is an FDA 510(k) clearance for the IMPLANTECH JEJ PERI-PYRIFORM IMPLANT. This device is classified as a Prosthesis, Nose, Internal (Class II - Special Controls, product code FZE).
Submitted by Implantech Associates, Inc. (Washington, US). The FDA issued a Cleared decision on October 3, 1996, 76 days after receiving the submission on July 19, 1996.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3680.
| 510(k) Number | K962824 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1996 |
| Decision Date | October 03, 1996 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FZE - Prosthesis, Nose, Internal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3680 |