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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Film, Radiographic
510(k) Number K790629
Device Name KODAK GRAY TONE IMAGING FILM
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 Number892.1840
Classification Product Code
IWZ  
Date Received03/29/1979
Decision Date 04/23/1979
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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