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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 K211001
Device Name C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner
Applicant
Medtec, Inc. Dba Civco Medical Solutions and Civco
Radiotherapy
1401 8th St. SE
Orange City,  IA  51041
Applicant Contact Alena Newgren
Correspondent
Medtec, Inc. Dba Civco Medical Solutions and Civco
1401 8th St. SE
Orange City,  IA  51041
Correspondent Contact Alena Newgren
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
LNH  
Date Received04/02/2021
Decision Date 05/20/2021
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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