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FDA 510(k) Application Details - K071348
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K071348
Device Name
Computer, Diagnostic, Programmable
Applicant
MENNEN MEDICAL LTD.
4 HA-YARDEN ST.
P.O. BOX 102
YAVNE, REHOVOT 76100 IL
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Contact
MICHA OESTEREICH
Other 510(k) Applications for this Contact
Regulation Number
870.1425
More FDA Info for this Regulation Number
Classification Product Code
DQK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/14/2007
Decision Date
09/07/2007
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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