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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 K182079
Device Name Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask
Applicant
MEDTEC Inc. dba CIVCO Medical Solutions
1401 8th Street SE
Orange City,  IA  51041 -3020
Applicant Contact Alena Newgren
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
LNH  
Date Received08/02/2018
Decision Date 09/07/2018
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
Recalls CDRH Recalls
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