PRECISION HARVEST & INLAY INSTRUMENT SET
FDA 510(k) clearance K851339 · decided 1985-07-02
Clearance details
- K-number
- K851339
- Device name
- PRECISION HARVEST & INLAY INSTRUMENT SET
- Applicant
- Concept, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-04-03
- Decision date
- 1985-07-02
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- HWK
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Clearwater, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HUNTER-SESSIONS VENA-CAVA OCCLUDER (P770005) | Concept, Inc. | 1977-12-19 |