The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Clavical Strap.
| Device ID | K823809 |
| 510k Number | K823809 |
| Device Name: | CLAVICAL STRAP |
| Classification | Splint, Clavicle |
| Applicant | DANEK MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IQJ |
| CFR Regulation Number | 890.3490 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-17 |
| Decision Date | 1983-01-14 |