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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 K930950
Device Name GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE
Applicant
W.L. GORE & ASSOCIATES,INC
3750 WEST KILTIE LN. DOCK-A
P.O. BOX 900
FLAGSTAFF,  AR  86002
Applicant Contact LARRY PRATT
Correspondent
W.L. GORE & ASSOCIATES,INC
3750 WEST KILTIE LN. DOCK-A
P.O. BOX 900
FLAGSTAFF,  AR  86002
Correspondent Contact LARRY PRATT
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received02/23/1993
Decision Date 10/22/1993
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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