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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 K983905
Device Name KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600
Applicant
EASTMAN KODAK COMPANY
901 ELMGROVE RD.
ROCHESTER,  NY  14653 -0002
Applicant Contact JUDITH A WALLACE
Correspondent
EASTMAN KODAK COMPANY
901 ELMGROVE RD.
ROCHESTER,  NY  14653 -0002
Correspondent Contact JUDITH A WALLACE
Regulation Number892.2040
Classification Product Code
LMC  
Date Received11/03/1998
Decision Date 01/25/1999
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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