The following data is part of a premarket notification filed by Implantech Associates, Inc. with the FDA for Trapezoidal Malar Implant.
| Device ID | K911513 |
| 510k Number | K911513 |
| Device Name: | TRAPEZOIDAL MALAR IMPLANT |
| Classification | Implant, Malar |
| Applicant | IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 |
| Contact | Dvorah A Richman |
| Correspondent | Dvorah A Richman IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 |
| Product Code | LZK |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-04 |
| Decision Date | 1991-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724TM41 | K911513 | 000 |
| M724TM31 | K911513 | 000 |
| M724TM21 | K911513 | 000 |
| M724TM51 | K911513 | 000 |
| M724TM11 | K911513 | 000 |