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510(k) K874787

MODIFIED PALLADIUM SEED MODEL 100 by Theragenics Corp. — Product Code IWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1987
Date Received
November 23, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Isotope, Sealed, Gold, Titanium, Platinum
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

Other clearances by Theragenics Corp.

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  • K010283 — THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 (April 26, 2001)

Other clearances for product code IWI

  • K973363 — NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL ME (July 2, 1998)
  • K940632 — I-125 RAPID STRAND (September 2, 1994)
  • K912170 — RADIOACTIVE IODINE-125 SOURCES (August 9, 1991)
  • K882449 — CESIUM 137 SOURCE, MODEL CSM-40 (April 14, 1989)
  • K852542 — PALLADIUM SEED MODEL 100 (January 14, 1986)