The following data is part of a premarket notification filed by Cutter Laboratories, Inc. with the FDA for C-splint.
| Device ID | K802104 | 
| 510k Number | K802104 | 
| Device Name: | C-SPLINT | 
| Classification | Orthosis, Limb Brace | 
| Applicant | CUTTER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | IQI | 
| CFR Regulation Number | 890.3475 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1980-09-03 | 
| Decision Date | 1980-09-16 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  C-SPLINT  73757772  1555644 Dead/Cancelled | JOHNSON & JOHNSON 1988-10-13 |