The following data is part of a premarket notification filed by King & Spalding with the FDA for Chin Implant Style I.
Device ID | K945998 |
510k Number | K945998 |
Device Name: | CHIN IMPLANT STYLE I |
Classification | Prosthesis, Chin, Internal |
Applicant | KING & SPALDING 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 -4706 |
Contact | Jill S Klein |
Correspondent | Jill S Klein KING & SPALDING 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 -4706 |
Product Code | FWP |
CFR Regulation Number | 878.3550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-30 |
Decision Date | 1995-02-07 |