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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
Recalls CDRH Recalls
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