The following data is part of a premarket notification filed by Applied Biomaterial Technologies with the FDA for The Permaridge Matrix Chin.
Device ID | K931500 |
510k Number | K931500 |
Device Name: | THE PERMARIDGE MATRIX CHIN |
Classification | Prosthesis, Chin, Internal |
Applicant | APPLIED BIOMATERIAL TECHNOLOGIES 3500 N.W. ANDERSON HILL RD. SUITE #101 SILVERDALE, WA 98383 |
Contact | GERALD HANSON |
Correspondent | GERALD HANSON APPLIED BIOMATERIAL TECHNOLOGIES 3500 N.W. ANDERSON HILL RD. SUITE #101 SILVERDALE, WA 98383 |
Product Code | FWP |
CFR Regulation Number | 878.3550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-25 |
Decision Date | 1994-11-17 |