FDA 510(k) Application Details - K973610

Device Classification Name Apparatus, Exhaust, Surgical

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510(K) Number K973610
Device Name Apparatus, Exhaust, Surgical
Applicant PYRAMID AIR SYSTEMS
122 HARRIS ST.
GRAINVALLEY, MO 64029 US
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Contact MARK MCKEE
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Regulation Number 878.5070

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Classification Product Code FYD
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Date Received 09/22/1997
Decision Date 12/19/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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