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FDA 510(k) K012098, PRECLUDE PERICARDIAL MEMBRANE, by W. L. Gore & Associates, Inc.

FDA 510(k) K012098, PRECLUDE PERICARDIAL MEMBRANE, by W. L. Gore & Associates, Inc.

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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
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