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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 K041500
Device Name STARPACS ORTHOPEDICS SYSTEM
Applicant
Infinitt Co., Ltd.
1600 Manchester Way
Denton,  TX  76210
Applicant Contact CARL ALLETTO
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact N.E. DEVINE, JR.
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/07/2004
Decision Date 06/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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