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510(k) K930570

RADIOACTIVE PALLADIUM 103 SEEDS/SOURCES by Best Industries — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1993
Date Received
February 4, 1993
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

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  • K912170 — RADIOACTIVE IODINE-125 SOURCES (August 9, 1991)
  • K910862 — VARIOUS TEMPLATE APPLICATORS (April 18, 1991)

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