The following data is part of a premarket notification filed by Implantech Associates Inc. with the FDA for Customized Contour Implant.
| Device ID | K191130 |
| 510k Number | K191130 |
| Device Name: | Customized Contour Implant |
| Classification | Prosthesis, Chin, Internal |
| Applicant | Implantech Associates Inc. 6025 Nicolle St., Suite B Ventura, CA 93003 |
| Contact | Craig Arthur |
| Correspondent | Pierre Bounaud AcKnowledge Regulatory Strategies 2251 San Diego Ave, Suite B-257 San Diego, CA 92110 |
| Product Code | FWP |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-29 |
| Decision Date | 2019-08-23 |