The following data is part of a premarket notification filed by Implantech Associates, Inc. with the FDA for Anatomical Mandibular Implant Style I.
| Device ID | K902826 |
| 510k Number | K902826 |
| Device Name: | ANATOMICAL MANDIBULAR IMPLANT STYLE I |
| Classification | Prosthesis, Chin, Internal |
| Applicant | IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 |
| Contact | Edward Basile |
| Correspondent | Edward Basile IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 |
| Product Code | FWP |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-28 |
| Decision Date | 1990-08-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724MPJCS1 | K902826 | 000 |
| M724MPJCXL1 | K902826 | 000 |
| M724MPJCM1 | K902826 | 000 |
| M724MPJCL1 | K902826 | 000 |
| M724MPJCSIZNS1 | K902826 | 000 |