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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K142986
Device Name SagiNova
Applicant
Eckert & Ziegler Bebig GmbH
Robert-Rossie-Str. 10
Berlin,  DE 13125
Applicant Contact Michel Lafuente
Correspondent
Capamed, Inc.
1917 29 3/4 Ave.
Rice Lake,  WI  54868
Correspondent Contact Lu Anne Johnson
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received10/16/2014
Decision Date 04/17/2015
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
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