FDA 510(k) Application Details - K101722

Device Classification Name

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510(K) Number K101722
Device Name ALYTE Y-MESH GRAFT
Applicant C.R. BARD, INC.
8195 INDUSTRIAL BLVD.
COVINGTON, GA 30014 US
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Contact SCOTT ROBIRDS
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Regulation Number

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Classification Product Code OTO
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Date Received 06/18/2010
Decision Date 04/01/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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