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FDA 510(k) Application Details - K072950
Device Classification Name
Analyzer, Pacemaker Generator Function, Indirect
More FDA Info for this Device
510(K) Number
K072950
Device Name
Analyzer, Pacemaker Generator Function, Indirect
Applicant
CYGNUS, LLC
510 EAST 41ST ST.
PATERSON, NJ 07504 US
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Contact
NARCIS NAYDENOV
Other 510(k) Applications for this Contact
Regulation Number
870.3640
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Classification Product Code
KRE
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More FDA Info for this Product Code
Date Received
10/18/2007
Decision Date
08/22/2008
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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