FDA 510(k), K140306, CORMATRIX PROTECT ECM ENVELOPE
FDA 510(k), K140306, CORMATRIX PROTECT ECM ENVELOPE
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510(K) Number: K140306
Device Name: CORMATRIX PROTECT ECM ENVELOPE
Manufacturer: CORMATRIX CARDIOVASCULAR, INC.
Device Classification Name: mesh, surgical
Regulation Number: 878.3300
Classification Product Code: FTM
Date Received: 02/07/2014
Decision Date: 08/15/2014
Regulation Medical Specialty: General & Plastic Surgery
Device Name: CORMATRIX PROTECT ECM ENVELOPE
Manufacturer: CORMATRIX CARDIOVASCULAR, INC.
Device Classification Name: mesh, surgical
Regulation Number: 878.3300
Classification Product Code: FTM
Date Received: 02/07/2014
Decision Date: 08/15/2014
Regulation Medical Specialty: General & Plastic Surgery
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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