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510(k) K010283

THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 by Theragenics Corp. — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2001
Date Received
January 30, 2001
Clearance Type
Traditional
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

Other clearances by Theragenics Corp.

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

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