FDA 510(k) Application Details - K012029

Device Classification Name Purifier, Water, Ultraviolet, Medical

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510(K) Number K012029
Device Name Purifier, Water, Ultraviolet, Medical
Applicant APOLLO CORP.
450 MAIN ST.
SOMERSET, WI 54025 US
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Contact ADRIAN SWEEN
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Regulation Number 880.6710

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Classification Product Code KMG
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Date Received 06/28/2001
Decision Date 12/31/2001
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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