The following data is part of a premarket notification filed by Implantech Associates, Inc. with the FDA for Extended Chin Implant Style Ii.
Device ID | K902825 |
510k Number | K902825 |
Device Name: | EXTENDED CHIN IMPLANT STYLE II |
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 |
---|---|---|
M724TEACM1 | K902825 | 000 |
M724TEACXL1 | K902825 | 000 |
M724CEACL1 | K902825 | 000 |
M724CEACM1 | K902825 | 000 |
M724CEACS1 | K902825 | 000 |
M724CEACXL1 | K902825 | 000 |
M724EACL1 | K902825 | 000 |
M724EACM1 | K902825 | 000 |
M724EACS1 | K902825 | 000 |
M724EACXL1 | K902825 | 000 |
M724TEACL1 | K902825 | 000 |
M724TEACS1 | K902825 | 000 |