The following data is part of a premarket notification filed by Dynasplint Systems, Inc. with the FDA for Universal Dynasplint.
| Device ID | K822767 |
| 510k Number | K822767 |
| Device Name: | UNIVERSAL DYNASPLINT |
| Classification | Orthosis, Limb Brace |
| Applicant | DYNASPLINT SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IQI |
| CFR Regulation Number | 890.3475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-14 |
| Decision Date | 1982-10-06 |