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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 K980060
Device Name ECHOLINK
Applicant
Mpacs, LLC
4828 Enchanted Valley Rd.
Middleton,  WI  53562 -4100
Applicant Contact DENNIS D ROSCOE
Correspondent
Mpacs, LLC
4828 Enchanted Valley Rd.
Middleton,  WI  53562 -4100
Correspondent Contact DENNIS D ROSCOE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/07/1998
Decision Date 02/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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