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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name digitizer, image, radiological
510(k) Number K013631
Device Name EFILM VIDEO
Applicant
EFILM MEDICAL, INC.
500 UNIVERSITY AVE., SUITE 300
TORONTO, ONTARIO,  CA M5G 1V7
Applicant Contact JOSEPH A THOMAS
Correspondent
ENTELA, INC.
3033 MADISON AVENUE, SE
GRAND RAPIDS,  MI  49548
Correspondent Contact N.E. DEVINE JR.
Regulation Number892.2030
Classification Product Code
LMA  
Date Received11/05/2001
Decision Date 11/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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