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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 K113311
Device Name TIO2MESH TM
Applicant
BIOCER ENTWICKLUNGS GMBH
611 WEST 5TH ST.
THIRD FLOOR
AUSTIN,  TX  78701
Applicant Contact CHERYL FISHER
Correspondent
BIOCER ENTWICKLUNGS GMBH
611 WEST 5TH ST.
THIRD FLOOR
AUSTIN,  TX  78701
Correspondent Contact CHERYL FISHER
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Code
OXJ  
Date Received11/09/2011
Decision Date 07/17/2012
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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