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FDA 510(k) Application Details - K043596
Device Classification Name
Source, Brachytherapy, Radionuclide
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510(K) Number
K043596
Device Name
Source, Brachytherapy, Radionuclide
Applicant
THERAGENICS CORP.
5203 BRISTOL INDUSTRIAL WAY
BUFORD, GA 30518 US
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Contact
BETSY CORTELLONI
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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
12/29/2004
Decision Date
01/26/2005
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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