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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Simulation, Radiation Therapy
510(k) Number K061006
Device Name IKOENGELO
Applicant
Ikoetech, LLC
3000 Richmond, Suite 200
Houston,  TX  77098
Applicant Contact HUIMIN CHAO
Correspondent
Ikoetech, LLC
3000 Richmond, Suite 200
Houston,  TX  77098
Correspondent Contact HUIMIN CHAO
Regulation Number892.5840
Classification Product Code
KPQ  
Subsequent Product Codes
IYE   MUJ  
Date Received04/11/2006
Decision Date 06/05/2006
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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