The following data is part of a premarket notification filed by Surgical Technology Laboratories, Inc. with the FDA for Standard Chin.
| Device ID | K983754 |
| 510k Number | K983754 |
| Device Name: | STANDARD CHIN |
| Classification | Prosthesis, Chin, Internal |
| Applicant | SURGICAL TECHNOLOGY LABORATORIES, INC. 1588 EAST 40TH ST. Cleveland, OH 44103 |
| Contact | Richard T Nock |
| Correspondent | Richard T Nock SURGICAL TECHNOLOGY LABORATORIES, INC. 1588 EAST 40TH ST. Cleveland, OH 44103 |
| Product Code | FWP |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-22 |
| Decision Date | 1998-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851988007716 | K983754 | 000 |
| 00851988007273 | K983754 | 000 |
| 00851988007266 | K983754 | 000 |
| 00851988007259 | K983754 | 000 |
| 00851988007242 | K983754 | 000 |
| 00851988007235 | K983754 | 000 |
| 00851988007228 | K983754 | 000 |
| 00850987007703 | K983754 | 000 |
| 00850987007697 | K983754 | 000 |
| 00850987007680 | K983754 | 000 |
| 00850987007673 | K983754 | 000 |
| 00850987007666 | K983754 | 000 |
| 00851988007280 | K983754 | 000 |
| 00851988007297 | K983754 | 000 |
| 00851988007303 | K983754 | 000 |
| 00851988007709 | K983754 | 000 |
| 00851988007693 | K983754 | 000 |
| 00851988007686 | K983754 | 000 |
| 00851988007679 | K983754 | 000 |
| 00851988007662 | K983754 | 000 |
| 00851988007402 | K983754 | 000 |
| 00851988007396 | K983754 | 000 |
| 00851988007389 | K983754 | 000 |
| 00851988007372 | K983754 | 000 |
| 00851988007327 | K983754 | 000 |
| 00851988007310 | K983754 | 000 |
| 00850987007659 | K983754 | 000 |