FDA 510(k) Application Details - K151702

Device Classification Name Aid, Cardiopulmonary Resuscitation

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510(K) Number K151702
Device Name Aid, Cardiopulmonary Resuscitation
Applicant LAERDAL MEDICAL AS
TANKE SVILANDSGATE 30
STAVANGER 4007 NO
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Contact MARI KAADA
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Regulation Number 870.5200

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Classification Product Code LIX
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Date Received 06/24/2015
Decision Date 08/13/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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