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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, Pre-Programmed, Single-Function
510(k) Number K032997
Device Name MODIFICATION TO: HORIZON 9000WS
Applicant
Mennen Medical , Ltd.
4 Hayarden St.
Yavne,  IL 81228
Applicant Contact EREZ NIMROD
Correspondent
Mennen Medical , Ltd.
4 Hayarden St.
Yavne,  IL 81228
Correspondent Contact EREZ NIMROD
Regulation Number870.1435
Classification Product Code
DXG  
Date Received09/25/2003
Decision Date 10/15/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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