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FDA 510(k) Application Details - K023805
Device Classification Name
Valve, Non-Rebreathing
More FDA Info for this Device
510(K) Number
K023805
Device Name
Valve, Non-Rebreathing
Applicant
LAERDAL MEDICAL A/S
TANKE SVILANDSGATE 30
STAVANGER 4002 NO
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Contact
MAGNE STEINSET
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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
11/14/2002
Decision Date
02/11/2003
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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