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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 K032635
Device Name DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300
Applicant
Agfa Corp.
10 S. Academy St.
Greenville,  SC  29601
Applicant Contact JEFF JEDLICKA
Correspondent
Agfa Corp.
10 S. Academy St.
Greenville,  SC  29601
Correspondent Contact JEFF JEDLICKA
Regulation Number892.2040
Classification Product Code
LMC  
Date Received08/26/2003
Decision Date 09/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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