MESH GPS - LARGE, SMALL, SM, SM SMALL
FDA 510(k) clearance K092726 · decided 2010-03-15
Clearance details
- K-number
- K092726
- Device name
- MESH GPS - LARGE, SMALL, SM, SM SMALL
- Applicant
- Surgical Structures , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-09-03
- Decision date
- 2010-03-15
- Days to decision
- 193 days
- Clearance type
- Traditional
- Product code
- OQL
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Chalotte, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.