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FDA 510(k) Application Details - K023798
Device Classification Name
Detector And Alarm, Arrhythmia
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510(K) Number
K023798
Device Name
Detector And Alarm, Arrhythmia
Applicant
MENNEN MEDICAL LTD.
4 HAYARDEN ST., YAVNE
P.O. BOX 102
REHOVOT 76100 IL
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Contact
EREZ NIMROD
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Regulation Number
870.1025
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Classification Product Code
DSI
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More FDA Info for this Product Code
Date Received
11/14/2002
Decision Date
12/03/2002
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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