The following data is part of a premarket notification filed by Far Orthopedics, Inc. with the FDA for Genucom.
Device ID | K834462 |
510k Number | K834462 |
Device Name: | GENUCOM |
Classification | Arthrometer |
Applicant | FAR ORTHOPEDICS, INC. MD |
Product Code | LYH |
CFR Regulation Number | 890.1615 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-19 |
Decision Date | 1984-02-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GENUCOM 73524488 1363160 Dead/Cancelled |
FAR ORTHOPEDICS INC. 1985-02-28 |