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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
510(k) Number K910464
Device Name GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE
Applicant
W. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
P.O. Box 500
Flagstaff,  AZ  86002
Applicant Contact BRIAN KUNST
Correspondent
W. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
P.O. Box 500
Flagstaff,  AZ  86002
Correspondent Contact BRIAN KUNST
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received02/04/1991
Decision Date 03/26/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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