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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K972847
Device Name KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D)
Applicant
EASTMAN KODAK COMPANY
901 ELMGROVE RD.
ROCHESTER,  NY  14653 -0002
Applicant Contact ROBERT L HILLER
Correspondent
EASTMAN KODAK COMPANY
901 ELMGROVE RD.
ROCHESTER,  NY  14653 -0002
Correspondent Contact ROBERT L HILLER
Regulation Number892.2040
Classification Product Code
LMC  
Date Received08/01/1997
Decision Date 10/07/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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