FDA 510(k) Application Details - K120728

Device Classification Name

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510(K) Number K120728
Device Name PHASIX PLUG AND PATCH
Applicant C.R. BARD INC
100 CROSSINGS BOULEVARD
WARWICK, RI 02886 US
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Contact SHERMA WINSTON
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Regulation Number

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Classification Product Code OWT
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Date Received 03/09/2012
Decision Date 10/22/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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