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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