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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 K003323
Device Name COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
Applicant
DAVOL, INC.
SUBSIDIARY OF C.R. BARD
100 SOCKANOSSETT CROSSROAD
CRANSTON,  RI  02920
Applicant Contact PAULA E BULGER
Correspondent
DAVOL, INC.
SUBSIDIARY OF C.R. BARD
100 SOCKANOSSETT CROSSROAD
CRANSTON,  RI  02920
Correspondent Contact PAULA E BULGER
Regulation Number878.3300
Classification Product Code
FTL  
Date Received10/24/2000
Decision Date 01/22/2001
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
Recalls CDRH Recalls
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