FDA 510(k) Application Details - K070254

Device Classification Name Computer, Diagnostic, Programmable

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510(K) Number K070254
Device Name Computer, Diagnostic, Programmable
Applicant MENNEN MEDICAL LTD.
4 HAYARDEN ST.
P.O. BOX 102 REHOVOT
YAVNE 76100 IL
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Contact MICHA OESTEREICH
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Regulation Number 870.1425

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Classification Product Code DQK
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Date Received 01/26/2007
Decision Date 04/19/2007
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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