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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 K022658
Device Name LR DICOM CONTROLLER
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 Received08/09/2002
Decision Date 09/06/2002
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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