FDA 510(k) Application Details - K033781

Device Classification Name Source, Brachytherapy, Radionuclide

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510(K) Number K033781
Device Name Source, Brachytherapy, Radionuclide
Applicant BEBIG ISOTOPEN-UND MEDIZINTECHNIK 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 12/04/2003
Decision Date 12/30/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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