FDA 510(k) Application Details - K170278

Device Classification Name Staple, Implantable

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510(K) Number K170278
Device Name Staple, Implantable
Applicant C.R. BARD INC.
100 CROSSINGS BOULEVARD
WARWICK, RI 02886 US
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Contact KATHERINE EARLE
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Regulation Number 878.4750

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Classification Product Code GDW
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Date Received 01/30/2017
Decision Date 05/31/2017
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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