The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for A.c. Splint.
| Device ID | K823810 |
| 510k Number | K823810 |
| Device Name: | A.C. SPLINT |
| Classification | Sling, Arm |
| Applicant | DANEK MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ILI |
| CFR Regulation Number | 890.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-17 |
| Decision Date | 1983-01-14 |