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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 K020995
Device Name EFILM WORKSTATION WITH MODULES
Applicant
Efilm Medical, Inc.
500 University Ave., Suite 300
Toronto, Ontario,  CA M5G 1V7
Applicant Contact JOSEPH A THOMAS
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact NEIL E DEVINE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/28/2002
Decision Date 04/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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