The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Softgood Products And Splints.
| Device ID | K803239 |
| 510k Number | K803239 |
| Device Name: | SOFTGOOD PRODUCTS AND SPLINTS |
| Classification | Orthosis, Rib Fracture, Soft |
| Applicant | DANEK MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IPX |
| CFR Regulation Number | 890.3490 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-23 |
| Decision Date | 1981-01-09 |