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FDA 510(k) Application Details - K973610
Device Classification Name
Apparatus, Exhaust, Surgical
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
878.5070
More FDA Info for this Regulation Number
Classification Product Code
FYD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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