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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 K002144
Device Name MEDLINK DIAGNOSTIC OFFLINE WORKSTATION
Applicant
Advanced Technology Laboratories, Inc.
22100 Bothell Everett Hwy
P.O. Box 3003
Bothell,  WA  98041 -3003
Applicant Contact TERRENCE J SWEENEY
Correspondent
Advanced Technology Laboratories, Inc.
22100 Bothell Everett Hwy
P.O. Box 3003
Bothell,  WA  98041 -3003
Correspondent Contact TERRENCE J SWEENEY
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/17/2000
Decision Date 09/28/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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