510(k) K834462
K834462 is an FDA 510(k) premarket notification submitted by Far Orthopedics, Inc. for the device "GENUCOM". The FDA issued a decision of Substantially Equivalent on February 9, 1984. The device falls under product code LYH (Arthrometer), a Class I device regulated under 21 CFR 890.1615. Far Orthopedics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 1984
- Date Received
- December 19, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Arthrometer
- Device Class
- Class I
- Regulation Number
- 890.1615
- Review Panel
- NE
- Submission Type