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FDA 510(k) Application Details - K041057
Device Classification Name
Conserver, Oxygen
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510(K) Number
K041057
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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More FDA Info for this Product Code
Date Received
04/23/2004
Decision Date
08/12/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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