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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 K033821
Device Name KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY
Applicant
Eastman Kodak Company
1 Imation Way
Oakdale,  MN  55128
Applicant Contact STEPHEN SLAVENS
Correspondent
Eastman Kodak Company
1 Imation Way
Oakdale,  MN  55128
Correspondent Contact STEPHEN SLAVENS
Regulation Number892.2040
Classification Product Code
LMC  
Date Received12/09/2003
Decision Date 02/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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