FDA 510(k) Application Details - K142656

Device Classification Name Suture, Absorbable, Natural

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510(K) Number K142656
Device Name Suture, Absorbable, Natural
Applicant COVIDIEN
60 MIDDLETOWN AVE.
NORTH HAVEN, CT 06473 US
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Contact Mary Mellows
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Regulation Number 878.4830

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Classification Product Code GAL
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Date Received 09/18/2014
Decision Date 01/29/2015
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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