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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 K030242
Device Name FYRELINK
Applicant
Mpacs, LLC
7601 Ganser Way
Madison,  WI  53719
Applicant Contact GREG SOPOTNICK
Correspondent
Mpacs, LLC
7601 Ganser Way
Madison,  WI  53719
Correspondent Contact GREG SOPOTNICK
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/23/2003
Decision Date 03/10/2003
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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