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FDA 510(k) Application Details - K984116
Device Classification Name
Cleaner, Air, Medical Recirculating
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510(K) Number
K984116
Device Name
Cleaner, Air, Medical Recirculating
Applicant
ABATEMENT TECHNOLOGIES, INC.
2220 NORTHMONT PKWY., #100
DULUTH, GA 30096 US
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Contact
DAVID WILLYARD
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Regulation Number
880.5045
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Classification Product Code
FRF
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Date Received
11/17/1998
Decision Date
06/24/1999
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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