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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Brachytherapy, Radionuclide
510(k) Number K040339
Device Name BRACHYTHERAPY STRAND DEVICE
Applicant
Bebig Isotopen-Und Medizintechnik GmbH
Robert-Rossle/Str.10
Berlin,  DE 13125
Applicant Contact SVEN LANGER
Correspondent
Bebig Isotopen-Und Medizintechnik GmbH
Robert-Rossle/Str.10
Berlin,  DE 13125
Correspondent Contact SVEN LANGER
Regulation Number892.5730
Classification Product Code
KXK  
Date Received02/11/2004
Decision Date 04/08/2004
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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