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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 K014183
Device Name AFB (ABSORBABLE FOAM BUTTRESS)
Applicant
J&J CORPORATE BIOMATERIALS CENTER
RT. 22 WEST, P.O. BOX 151
SOMEVILLE,  NJ  08876 -0151
Applicant Contact DAVID A DALESSANDRO
Correspondent
J&J CORPORATE BIOMATERIALS CENTER
RT. 22 WEST, P.O. BOX 151
SOMEVILLE,  NJ  08876 -0151
Correspondent Contact DAVID A DALESSANDRO
Regulation Number878.3300
Classification Product Code
FTL  
Date Received12/20/2001
Decision Date 06/12/2002
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
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