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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 K093932
Device Name ETHICON PHYSIOMESH, FLEXIBLE COMPOSITE MESH
Applicant
ETHICON GMBH
rt 22 west p.o. box 151
somerville,  NJ  08876
Applicant Contact neelu medhekar
Correspondent
ETHICON GMBH
rt 22 west p.o. box 151
somerville,  NJ  08876
Correspondent Contact neelu medhekar
Regulation Number878.3300
Classification Product Code
FTL  
Date Received12/22/2009
Decision Date 04/09/2010
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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