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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name screen, intensifying, radiographic
510(k) Number K770094
Device Name FLUORICON 500 IMAGE INTENSIFIERS
Applicant
GENERAL ELECTRIC CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GENERAL ELECTRIC CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number892.1960
Classification Product Code
EAM  
Date Received01/17/1977
Decision Date 01/21/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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