MESO TENDON MATRIX
FDA 510(k) clearance K133169 · decided 2013-12-20
Clearance details
- K-number
- K133169
- Device name
- MESO TENDON MATRIX
- Applicant
- Kensey Nash Corporation Dba Dsm Biomedical
- Decision
- Substantially Equivalent
- Date received
- 2013-10-17
- Decision date
- 2013-12-20
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- OWY
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Exton, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.