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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical, polymeric
510(k) Number K945899
Device Name GORE-TEX(R) CURVED SURGICALMEMBRANE
Applicant
W.L. GORE & ASSOCIATES,INC
3750 WEST KILTIE LAND DOCK A
P.O. BOX 900
FLAGSTAFF,  AZ  86002 -0900
Applicant Contact R L PRATT
Correspondent
W.L. GORE & ASSOCIATES,INC
3750 WEST KILTIE LAND DOCK A
P.O. BOX 900
FLAGSTAFF,  AZ  86002 -0900
Correspondent Contact R L PRATT
Regulation Number878.3300
Classification Product Code
FTL  
Date Received12/02/1994
Decision Date 02/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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