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FDA 510(k) Application Details - K173886
Device Classification Name
Aid, Cardiopulmonary Resuscitation
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510(K) Number
K173886
Device Name
Aid, Cardiopulmonary Resuscitation
Applicant
Laerdal Medical AS
Tanke Svilandsgate 30
Stavanger 2007 NO
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Contact
Mari Kaada
Other 510(k) Applications for this Contact
Regulation Number
870.5200
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Classification Product Code
LIX
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More FDA Info for this Product Code
Date Received
12/21/2017
Decision Date
03/23/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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