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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K141900
Device Name SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE
Applicant
Eckert & Ziegler Bebig GmbH
Muurzwaluw 30
Veenendaal,  NL 3905RZ
Applicant Contact HUB VAN DE BERGH
Correspondent
Eckert & Ziegler Bebig GmbH
Muurzwaluw 30
Veenendaal,  NL 3905RZ
Correspondent Contact HUB VAN DE BERGH
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received07/14/2014
Decision Date 05/20/2015
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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