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FDA 510(k) Application Details - K043336
Device Classification Name
Source, Brachytherapy, Radionuclide
More FDA Info for this Device
510(K) Number
K043336
Device Name
Source, Brachytherapy, Radionuclide
Applicant
IBT SA
6000 LIVE OAK PARKWAY, STE 107
NORCROSS, GA 30093 US
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Contact
RUTH FEICHT
Other 510(k) Applications for this Contact
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
12/03/2004
Decision Date
01/21/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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