FDA 510(k) Application Details - K071807

Device Classification Name Mesh, Surgical

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510(K) Number K071807
Device Name Mesh, Surgical
Applicant TEI BIOSCIENCES INC.
7 ELKINS ST.
BOSTON, MA 02127 US
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Contact KENNETH JAMES
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Regulation Number 878.3300

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Classification Product Code FTM
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Date Received 07/02/2007
Decision Date 08/06/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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