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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
510(k) Number K071807
Device Name ORTHOMEND SOFT TISSUE MATRIX
Applicant
TEI BIOSCIENCES INC.
7 ELKINS ST.
BOSTON,  MA  02127
Applicant Contact KENNETH JAMES
Correspondent
TEI BIOSCIENCES INC.
7 ELKINS ST.
BOSTON,  MA  02127
Correspondent Contact KENNETH JAMES
Regulation Number878.3300
Classification Product Code
FTM  
Date Received07/02/2007
Decision Date 08/06/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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