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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name computer, diagnostic, programmable
510(k) Number K043564
Device Name HORIZON ANGIO CATHLAB
Applicant
MENNEN MEDICAL LTD.
4 ha-yarden st.
p.o. box 102
yavne, rehovot,  IL 81228
Applicant Contact micha oestereich
Correspondent
MENNEN MEDICAL LTD.
4 ha-yarden st.
p.o. box 102
yavne, rehovot,  IL 81228
Correspondent Contact micha oestereich
Regulation Number870.1425
Classification Product Code
DQK  
Date Received12/27/2004
Decision Date 01/27/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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