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FDA 510(k) Application Details - K974682
Device Classification Name
Cleaner, Air, Medical Recirculating
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510(K) Number
K974682
Device Name
Cleaner, Air, Medical Recirculating
Applicant
BIOLOGICAL CONTROLS, INC.
ONE INDUSTRIAL WAY WEST
BUILDING E, UNIT M
EATONTOWN, NJ 07724 US
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Contact
GARY D MESSINA
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Regulation Number
880.5045
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Classification Product Code
FRF
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More FDA Info for this Product Code
Date Received
12/15/1997
Decision Date
01/23/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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