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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K180021
Device Name Proton Positioing and Immobilization Devices
Applicant
Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap
140 8th St. SE
Orange City,  IA  51041
Applicant Contact Alena Newgren
Correspondent
Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap
140 8th St. SE
Orange City,  IA  51041
Correspondent Contact Alena Newgren
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Codes
IXQ   LNH  
Date Received01/03/2018
Decision Date 06/29/2018
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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