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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 K052251
Device Name DRYSTAR MODEL 5500
Applicant
AGFA CORPORATION
10 SOUTH ACADEMY STREET
GREENVILLE,  SC  29602 -9048
Applicant Contact JEFF JEDLICKA
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Regulation Number892.2040
Classification Product Code
LMC  
Date Received08/18/2005
Decision Date 08/31/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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