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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 K770837
Device Name SCREEN, FINE, LANES, KODAK
Applicant
Eastman Kodak Company
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Eastman Kodak Company
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.1960
Classification Product Code
EAM  
Date Received05/06/1977
Decision Date 05/26/1977
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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