FDA 510(k) Application Details - K140849

Device Classification Name Source, Brachytherapy, Radionuclide

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510(K) Number K140849
Device Name Source, Brachytherapy, Radionuclide
Applicant ECKERT & ZIEGLER BEBIG GMBH
ROBERT-ROSSLE STR.10
BERLIN 13125 DE
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Contact SVEN LANGER
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Regulation Number 892.5730

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Classification Product Code KXK
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Date Received 04/03/2014
Decision Date 07/02/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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