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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K904590
Device Name KODAK EKTASCAN LASER PRINTER, MODEL 100 XLP
Applicant
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650
Applicant Contact NORMAN H GEIL
Correspondent
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650
Correspondent Contact NORMAN H GEIL
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/09/1990
Decision Date 11/13/1990
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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