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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Burr Hole
510(k) Number K960656
Device Name GORE BURR HOLE COVER
Applicant
W. L. Gore & Associates, Inc.
3750 W. Kiltie Ln.
Flagstaff,  AZ  86001
Applicant Contact JOHN W NICHOLSON
Correspondent
W. L. Gore & Associates, Inc.
3750 W. Kiltie Ln.
Flagstaff,  AZ  86001
Correspondent Contact JOHN W NICHOLSON
Regulation Number882.5250
Classification Product Code
GXR  
Date Received02/15/1996
Decision Date 08/14/1996
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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