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 |