FDA 510(k) Application Details - K142335

Device Classification Name Apparatus, Exhaust, Surgical

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510(K) Number K142335
Device Name Apparatus, Exhaust, Surgical
Applicant COVIDIEN
15 HAMPSHIRE STREET
MANSFILED, MA 02048 US
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Contact JOSE MARQUEZ
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Regulation Number 878.5070

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Classification Product Code FYD
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Date Received 08/21/2014
Decision Date 01/14/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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