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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 K002684
Device Name COMPOSIX E/X MESH
Applicant
C.R. Bard, Inc.
100 Sockanossett Crossroad
Canston,  RI  02920
Applicant Contact RUTH C FORSTADT
Correspondent
C.R. Bard, Inc.
100 Sockanossett Crossroad
Canston,  RI  02920
Correspondent Contact RUTH C FORSTADT
Regulation Number878.3300
Classification Product Code
FTL  
Date Received08/28/2000
Decision Date 10/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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