GENUCOM
FDA 510(k) clearance K834462 · decided 1984-02-09
Clearance details
- K-number
- K834462
- Device name
- GENUCOM
- Applicant
- Far Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-12-19
- Decision date
- 1984-02-09
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- LYH
- Device class
- 1
- Regulation number
- 890.1615
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| KT1000/S KNEE LIGAMENT ARTHROMETER (K943197) | Medmetric Corp. | 1995-03-02 |
| KT2000 KNEE LIGAMENT ARTHROMETER (K942059) | Medmetric Corp. | 1994-09-20 |
| DYNAMIC CRUCIATE TESTER (K881876) | Dyonics, Inc. | 1988-11-17 |
| KT-1000 DEVICE (K812806) | Medmetric Corp. | 1981-11-10 |
Recalls involving this device
No recalls on record reference this clearance.