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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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More FDA Info for this Product Code
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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