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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K051258
Device Name KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345
Applicant
EASTMAN KODAK COMPANY
343 STATE STREET
ROCHESTER,  NY  14650
Applicant Contact CHRISTINE E EHMANN
Correspondent
EASTMAN KODAK COMPANY
343 STATE STREET
ROCHESTER,  NY  14650
Correspondent Contact CHRISTINE E EHMANN
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received05/16/2005
Decision Date 06/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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