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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 K042158
Device Name KODAK MEDICAL IMAGER 300
Applicant
EASTMAN KODAK COMPANY
1 IMATION WAY
304-3B-61
OAKDALE,  MN  55128 -3414
Applicant Contact STEPHEN SLAVENS
Correspondent
EASTMAN KODAK COMPANY
1 IMATION WAY
304-3B-61
OAKDALE,  MN  55128 -3414
Correspondent Contact STEPHEN SLAVENS
Regulation Number892.2040
Classification Product Code
LMC  
Date Received08/10/2004
Decision Date 09/24/2004
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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