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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 K984534
FOIA Releasable 510(k) K984534
Device Name PRECLUDE ACUSEAL DURA SUBSTITUTE
Applicant
W.L. Gore & Associates, Inc.
301 Airport Rd.
Elkton,  MD  21922 -1408
Applicant Contact JOHN NICHOLSON
Correspondent
W.L. Gore & Associates, Inc.
301 Airport Rd.
Elkton,  MD  21922 -1408
Correspondent Contact JOHN NICHOLSON
Regulation Number882.5910
Classification Product Code
GXQ  
Date Received12/21/1998
Decision Date 03/15/1999
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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