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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K131854
Device Name CEROX
Applicant
Or-Nim Medical , Ltd.
15 Atir Yeda St.
Kfar Saba,  IL 4464312
Applicant Contact MICHA OESTEREICH
Correspondent
Or-Nim Medical , Ltd.
15 Atir Yeda St.
Kfar Saba,  IL 4464312
Correspondent Contact MICHA OESTEREICH
Regulation Number870.2100
Classification Product Code
DPW  
Date Received06/21/2013
Decision Date 09/13/2013
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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