The following data is part of a premarket notification filed by Surgical Technology Laboratories, Inc. with the FDA for Straith Chin Implants.
| Device ID | K801073 |
| 510k Number | K801073 |
| Device Name: | STRAITH CHIN IMPLANTS |
| Classification | Prosthesis, Chin, Internal |
| Applicant | SURGICAL TECHNOLOGY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FWP |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-06 |
| Decision Date | 1980-05-20 |