• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
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FDA 510(k) K021477, PRECLUDE MVP DURA SUBSTITUTE, by W. L. Gore & Associates, Inc.

FDA 510(k) K021477, PRECLUDE MVP DURA SUBSTITUTE, by W. L. Gore & Associates, Inc.

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510(K) Number: K021477
Device Name: PRECLUDE MVP DURA SUBSTITUTE
Manufacturer: W. L. Gore & Associates, Inc.
Device Classification Name: dura substitute
Regulation Number: 882.5910
Classification Product Code: GXQ
Date Received: 05/08/2002
Decision Date: 11/08/2002
Regulation Medical Specialty: Neurology
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