FDA 510(k) Application Details - K121139

Device Classification Name

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510(K) Number K121139
Device Name ACCUMESH DEPLOYMENT SYSTEM
Applicant Covidien LLC
15 CROSBY DR
BEDFORD, MA 01730 US
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Contact JAMES MCMAHON
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Regulation Number

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Classification Product Code ORQ
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Date Received 04/16/2012
Decision Date 05/02/2012
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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