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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Angiographic
510(k) Number K073328
Device Name CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA
Applicant
Paieon, Inc.
22 Hamelacha St., P.O.B. 11355
Rosh Haayin,  IL 48901
Applicant Contact RAVIT BARKAMA
Correspondent
Paieon, Inc.
22 Hamelacha St., P.O.B. 11355
Rosh Haayin,  IL 48901
Correspondent Contact RAVIT BARKAMA
Regulation Number892.1600
Classification Product Code
IZI  
Date Received11/27/2007
Decision Date 09/09/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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