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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 K905801
Device Name CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO
Applicant
Cemax, Inc.
46759 Fremont Blvd., Suite 207
Fremont,  CA  94538
Applicant Contact DOUGLAS A MERK
Correspondent
Cemax, Inc.
46759 Fremont Blvd., Suite 207
Fremont,  CA  94538
Correspondent Contact DOUGLAS A MERK
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/28/1990
Decision Date 03/22/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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