CORMATRIX PROTECT ECM ENVELOPE
FDA 510(k) clearance K140306 · decided 2014-08-15
Clearance details
- K-number
- K140306
- Device name
- CORMATRIX PROTECT ECM ENVELOPE
- Applicant
- Cormatrix Cardiovascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-02-07
- Decision date
- 2014-08-15
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- FTM
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Roswell, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.