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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 K032174
Device Name WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A
Applicant
Wide Corporation
1100 Lakeview Blvd.
Denton,  TX  76208
Applicant Contact CARL ALLETTO
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact NED E DEVINE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/16/2003
Decision Date 07/24/2003
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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