K191130 is an FDA 510(k) clearance for the Customized Contour Implant. This device is classified as a Prosthesis, Chin, Internal (Class II - Special Controls, product code FWP).
Submitted by Implantech Associates, Inc. (Ventura, US). The FDA issued a Cleared decision on August 23, 2019, 116 days after receiving the submission on April 29, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3550.
| 510(k) Number | K191130 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 2019 |
| Decision Date | August 23, 2019 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FWP - Prosthesis, Chin, Internal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3550 |