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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bone grafting material, synthetic
510(k) Number K013346
Device Name GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE
Applicant
W.L. GORE & ASSOCIATES,INC
3450 KILTIE LN.
P.O. BOX 500
FLAGSTAFF,  AZ  86002 -0500
Applicant Contact JACQUELINE KALBACH
Correspondent
W.L. GORE & ASSOCIATES,INC
3450 KILTIE LN.
P.O. BOX 500
FLAGSTAFF,  AZ  86002 -0500
Correspondent Contact JACQUELINE KALBACH
Regulation Number872.3930
Classification Product Code
LYC  
Date Received10/09/2001
Decision Date 12/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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