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FDA 510(k) Application Details - K013631
Device Classification Name
Digitizer, Image, Radiological
More FDA Info for this Device
510(K) Number
K013631
Device Name
Digitizer, Image, Radiological
Applicant
EFILM MEDICAL, INC.
500 UNIVERSITY AVE., SUITE 300
TORONTO, ONTARIO M5G 1V7 CA
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Contact
JOSEPH A THOMAS
Other 510(k) Applications for this Contact
Regulation Number
892.2030
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Classification Product Code
LMA
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More FDA Info for this Product Code
Date Received
11/05/2001
Decision Date
11/20/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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