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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prostate Immobilizer Rectal Balloon
510(k) Number K180478
Device Name RectalPro 75 Endorectal Balloon
Applicant
QLRAD International Ltd.
Wormerweg 6
Almere,  NL 1311 XB
Applicant Contact Arjen Winkel
Correspondent
Emergo Global Consulting , LLC
2500 Bee Cave Road, Building 1, Suite 300
Austin,  TX  78746
Correspondent Contact Audrey Swearingen
Regulation Number892.5720
Classification Product Code
PCT  
Date Received02/22/2018
Decision Date 11/13/2018
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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