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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 K833764
Device Name STERILIZATION OF GORE-TEX SOFT TISSU
Applicant
W.L. GORE & ASSOCIATES,INC
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
W.L. GORE & ASSOCIATES,INC
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.3300
Classification Product Code
FTL  
Date Received10/26/1983
Decision Date 01/10/1984
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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