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FDA 510(k) Application Details - K112660
Device Classification Name
Aid, Cardiopulmonary Resuscitation
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510(K) Number
K112660
Device Name
Aid, Cardiopulmonary Resuscitation
Applicant
ZOLL MEDICAL CORP.
525 NARRAGANSETT PARK DRIVE
PAWTUCKET, RI 02861 US
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Contact
ROBERT MORSE
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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
09/13/2011
Decision Date
05/10/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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