The following data is part of a premarket notification filed by Applied Biomaterial Technologies with the FDA for The Magnum Chin Implant.
Device ID | K902285 |
510k Number | K902285 |
Device Name: | THE MAGNUM CHIN IMPLANT |
Classification | Prosthesis, Chin, Internal |
Applicant | APPLIED BIOMATERIAL TECHNOLOGIES 851 SIXTH ST. S#145 BREMERTON, WA 98310 |
Contact | L HANSON |
Correspondent | L HANSON APPLIED BIOMATERIAL TECHNOLOGIES 851 SIXTH ST. S#145 BREMERTON, WA 98310 |
Product Code | FWP |
CFR Regulation Number | 878.3550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-22 |
Decision Date | 1990-09-12 |