FDA 510(k) Application Details - K023805

Device Classification Name Valve, Non-Rebreathing

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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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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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