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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Couch, Radiation Therapy, Powered
510(k) Number K132084
Device Name PROTURA COUCH SOFTWARE
Applicant
Med-Tec, Inc. D/B/A Civco Medical Solutions
1401 8th St. SE
Orange City,  IA  51041
Applicant Contact AMANDA STAHLE
Correspondent
Med-Tec, Inc. D/B/A Civco Medical Solutions
1401 8th St. SE
Orange City,  IA  51041
Correspondent Contact AMANDA STAHLE
Regulation Number892.5770
Classification Product Code
JAI  
Date Received07/05/2013
Decision Date 09/26/2013
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
Recalls CDRH Recalls
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