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FDA 510(k) Application Details - K142402
Device Classification Name
Valve, Non-Rebreathing
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510(K) Number
K142402
Device Name
Valve, Non-Rebreathing
Applicant
12th Man Technologies, Inc.
7245 Garden Grove Blvd., Suite C
Garden Grove, CA 92841 US
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Contact
Alex Stenzler
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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
08/27/2014
Decision Date
03/23/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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