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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 K970154
Device Name KODAK EKTASIAN HG FILM (EHG-15)
Applicant
Eastman Kodak Company
1669 Lake Ave.
Rochester,  NY  14652
Applicant Contact MARIA DURKIN
Correspondent
Eastman Kodak Company
1669 Lake Ave.
Rochester,  NY  14652
Correspondent Contact MARIA DURKIN
Regulation Number892.1840
Classification Product Code
IWZ  
Date Received01/16/1997
Decision Date 04/04/1997
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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