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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K090481
Device Name DEMASQ IMAGING SPFTWARE DEVICE
Applicant
Demasq Limited
8th Floor Eastgate House
34-43 Newport Rd.
Cardiff Wales,  GB CF240AB
Applicant Contact STUART GALL
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF RONGERO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/24/2009
Decision Date 03/19/2009
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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