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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 S. Academy St.
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
Predetermined Change
Control Plan Authorized		 No
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