FDA 510(k), K012098, PRECLUDE PERICARDIAL MEMBRANE
FDA 510(k), K012098, PRECLUDE PERICARDIAL MEMBRANE
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510(K) Number: K012098
Device Name: PRECLUDE PERICARDIAL MEMBRANE
Manufacturer: W.L. GORE & ASSOCIATES,INC
Device Classification Name: patch, pledget and intracardiac, petp, ptfe, polypropylene
Regulation Number: 870.3470
Classification Product Code: DXZ
Date Received: 07/05/2001
Decision Date: 09/20/2001
Regulation Medical Specialty: Cardiovascular
Device Name: PRECLUDE PERICARDIAL MEMBRANE
Manufacturer: W.L. GORE & ASSOCIATES,INC
Device Classification Name: patch, pledget and intracardiac, petp, ptfe, polypropylene
Regulation Number: 870.3470
Classification Product Code: DXZ
Date Received: 07/05/2001
Decision Date: 09/20/2001
Regulation Medical Specialty: Cardiovascular