CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM
FDA 510(k) clearance K101534 · decided 2010-11-24
Clearance details
- K-number
- K101534
- Device name
- CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM
- Applicant
- Conmedcorp
- Decision
- Substantially Equivalent
- Date received
- 2010-06-03
- Decision date
- 2010-11-24
- Days to decision
- 174 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Centennial, CO, US
- Third-party review
- Yes
- Expedited review
- No
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