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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 K993283
Device Name OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C
Applicant
Arnold & Richter Cine Technik
89 Turkenstrasse
Munich,  DE 80799
Applicant Contact THOMAS POPP
Correspondent
Arnold & Richter Cine Technik
89 Turkenstrasse
Munich,  DE 80799
Correspondent Contact THOMAS POPP
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/30/1999
Decision Date 12/29/1999
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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