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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 K060210
Device Name MEDIPORT
Applicant
Maxant Technologies, Inc.
7540 Caldwell Ave.
Niles,  IL  60714
Applicant Contact DONALD P DEVALE
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact GLEN LUCHEN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/27/2006
Decision Date 02/10/2006
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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