SURGICAL TISSUE MANAGEMENT SYSTEM
FDA 510(k) clearance K111202 · decided 2012-01-20
Clearance details
- K-number
- K111202
- Device name
- SURGICAL TISSUE MANAGEMENT SYSTEM
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2011-04-29
- Decision date
- 2012-01-20
- Days to decision
- 266 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
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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