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FDA 510(k) Application Details - K033781
Device Classification Name
Source, Brachytherapy, Radionuclide
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
892.5730
More FDA Info for this Regulation Number
Classification Product Code
KXK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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