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FDA 510(k) Application Details - K052458
Device Classification Name
Valve, Non-Rebreathing
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510(K) Number
K052458
Device Name
Valve, Non-Rebreathing
Applicant
LIV MEDICA PRODUCTS PVT. LTD.
458 BRIARCREEK DRIVE
HOCKESSIN, DE 19707 US
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Contact
MICHAEL HOLSTEIN
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Regulation Number
868.5870
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Classification Product Code
CBP
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More FDA Info for this Product Code
Date Received
09/07/2005
Decision Date
07/07/2006
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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