FDA 510(k) Application Details - K131402

Device Classification Name Apparatus, Exhaust, Surgical

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510(K) Number K131402
Device Name Apparatus, Exhaust, Surgical
Applicant BUFFALO FILTER CO., INC.
5900 GENESEE STREET
LANCASTER, NY 14086 US
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Contact CARRIE TERMIN
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Regulation Number 878.5070

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Classification Product Code FYD
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Date Received 05/15/2013
Decision Date 03/03/2014
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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