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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K950513
Device Name ARCHIVEMANAGER
Applicant
CEMAX, INC.
47281 MISSION FALLS COURT
FREMONT,  CA  94539
Applicant Contact DOUGLAS A MERK
Correspondent
CEMAX, INC.
47281 MISSION FALLS COURT
FREMONT,  CA  94539
Correspondent Contact DOUGLAS A MERK
Regulation Number892.2020
Classification Product Code
LMD  
Date Received02/06/1995
Decision Date 11/13/1995
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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