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FDA 510(k) Application Details - K102299
Device Classification Name
Valve, Non-Rebreathing
More FDA Info for this Device
510(K) Number
K102299
Device Name
Valve, Non-Rebreathing
Applicant
GENUINE FIRST AID LLC
150 CHERRY LANE RD.
EAST STROUDSBURG, PA 18301 US
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Contact
Gary Lehnus
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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
08/13/2010
Decision Date
03/18/2011
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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