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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 K061934
Device Name XTAC
Applicant
OSTEOGENICS, INC.
7781 LAKEVIEW DR.
BURLINGTON,  WI  53105 -8119
Applicant Contact MICHAEL DEUTSCH
Correspondent
OSTEOGENICS, INC.
7781 LAKEVIEW DR.
BURLINGTON,  WI  53105 -8119
Correspondent Contact MICHAEL DEUTSCH
Regulation Number878.3300
Classification Product Code
FTL  
Date Received07/07/2006
Decision Date 07/17/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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