ECLIPSE 3200 FOR USE IN ORTHO SURG/ARTH APPL JOINT
FDA 510(k) clearance K931306 · decided 1993-07-23
Clearance details
- K-number
- K931306
- Device name
- ECLIPSE 3200 FOR USE IN ORTHO SURG/ARTH APPL JOINT
- Applicant
- Cardiogenes
- Decision
- Substantially Equivalent
- Date received
- 1993-03-15
- Decision date
- 1993-07-23
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.