FDA 510(k) Application Details - K123066

Device Classification Name

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510(K) Number K123066
Device Name ACCUMESH DEPLOYMENT SYSTEM
Applicant Covidien LLC
15 CROSBY DRIVE
BEDFORD, MA 01730 US
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Contact ELIZABETH MCMENIMAN
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Regulation Number

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Classification Product Code ORQ
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Date Received 10/01/2012
Decision Date 10/16/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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