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510(k) K103319

I-SEED by Theragenics Corp. — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2011
Date Received
November 12, 2010
Clearance Type
Abbreviated
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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