The following data is part of a premarket notification filed by Cutter Laboratories, Inc. with the FDA for Ulnar Head Prothesis.
Device ID | K790125 |
510k Number | K790125 |
Device Name: | ULNAR HEAD PROTHESIS |
Classification | Prosthesis, Wrist, Hemi-, Ulnar |
Applicant | CUTTER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KXE |
CFR Regulation Number | 888.3810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-23 |
Decision Date | 1979-02-08 |