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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 K031013
Device Name INFINTT CO., LTD. STARPACS SYSTEM
Applicant
Infinitt Company
1100 Lakeview Blvd.
Denton,  TX  76208
Applicant Contact CARL ALLETTO
Correspondent
Infinitt Company
1100 Lakeview Blvd.
Denton,  TX  76208
Correspondent Contact CARL ALLETTO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/31/2003
Decision Date 04/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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