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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 K122201
Device Name PROTURA COUCH SOFTWARE
Original Applicant
MED-TEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS
1401 8th street se
orange city,  IA  51041
Original Contact amanda stahle
Regulation Number892.5770
Classification Product Code
JAI  
Date Received07/25/2012
Decision Date 08/30/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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