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 |