FDA 510(k) Application Details - K023693

Device Classification Name Cleaner, Air, Medical Recirculating

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510(K) Number K023693
Device Name Cleaner, Air, Medical Recirculating
Applicant AIREX INC.
13704 S.E. 17TH ST.
BELLEVUE, WA 98005 US
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Contact WILLIAM HASLEBACHER
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Regulation Number 880.5045

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Classification Product Code FRF
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Date Received 11/01/2002
Decision Date 03/12/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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