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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 K023476
Device Name UNIPACS WORKSTATION
Applicant
Universal Pacs, Inc.
127 Albert Hart Dr.
Baton Rouge,  LA  70803
Applicant Contact JOHN M TYLER
Correspondent
Universal Pacs, Inc.
127 Albert Hart Dr.
Baton Rouge,  LA  70803
Correspondent Contact JOHN M TYLER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/16/2002
Decision Date 01/07/2003
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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