FDA 510(k) Application Details - K161424

Device Classification Name Surgical Film

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510(K) Number K161424
Device Name Surgical Film
Applicant C.R. BARD INC.
100 CROSSINGS BOULEVARD
WARWICK, RI 02886 US
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Contact JANNA BABSON
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Regulation Number 878.3300

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Classification Product Code OOD
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Date Received 05/23/2016
Decision Date 09/29/2016
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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