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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dura Substitute
510(k) Number K021477
FOIA Releasable 510(k) K021477
Device Name PRECLUDE MVP DURA SUBSTITUTE
Applicant
W. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
Flagstaff,  AZ  86001
Applicant Contact TIMOTHY J RYNN
Correspondent
W. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
Flagstaff,  AZ  86001
Correspondent Contact TIMOTHY J RYNN
Regulation Number882.5910
Classification Product Code
GXQ  
Date Received05/08/2002
Decision Date 11/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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