FDA 510(k) Application Details - K060382

Device Classification Name Conserver, Oxygen

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510(K) Number K060382
Device Name Conserver, Oxygen
Applicant AMERIFLO CORP.
478 GRADLE DR.
CARMEL, IN 46032 US
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Contact MATTHEW THIE
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Regulation Number 868.5905

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Classification Product Code NFB
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Date Received 02/14/2006
Decision Date 04/19/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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