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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K072960
Device Name CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET
Applicant
CDP, LTD.
23 EFAL STREET
P.O. BOX 3325
KIRIAT ARIE, PETACH TIKVA,  IL 49130
Applicant Contact DORON DAVID
Correspondent
KEMA QUALITY B.V.
4377 COUNTY LINE ROAD
CHALFONT,  PA  18914
Correspondent Contact HARRY VAN VUGT
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/19/2007
Decision Date 11/08/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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