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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 K091364
Device Name DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4
Applicant
Oehm Und Rehbein GmbH
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact ALAN SCHWARTZ
Correspondent
Oehm Und Rehbein GmbH
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact ALAN SCHWARTZ
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/08/2009
Decision Date 12/11/2009
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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