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510(k) K043596

THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 by Theragenics Corp. — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2005
Date Received
December 29, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Brachytherapy, Radionuclide
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

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  • K874787 — MODIFIED PALLADIUM SEED MODEL 100 (December 22, 1987)

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