The following data is part of a premarket notification filed by Surgical Technology Laboratories, Inc. with the FDA for Straith Nasal Splint.
| Device ID | K801072 |
| 510k Number | K801072 |
| Device Name: | STRAITH NASAL SPLINT |
| Classification | Appliance, Facial Fracture, External |
| Applicant | SURGICAL TECHNOLOGY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FYI |
| CFR Regulation Number | 878.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-06 |
| Decision Date | 1980-06-17 |