The following data is part of a premarket notification filed by Implantech Associates, Inc. with the FDA for Implantech Composite Facial Implants (malar, Chin, And Nasal).
| Device ID | K002886 |
| 510k Number | K002886 |
| Device Name: | IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) |
| Classification | Implant, Malar |
| Applicant | IMPLANTECH ASSOCIATES, INC. 2064 EASTMAN AVE., UNIT 101 Ventura, CA 93003 |
| Contact | Edward Leicht |
| Correspondent | Edward Leicht IMPLANTECH ASSOCIATES, INC. 2064 EASTMAN AVE., UNIT 101 Ventura, CA 93003 |
| Product Code | LZK |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-15 |
| Decision Date | 2000-11-24 |