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510(k) K850382

IRIDIUM SEEDS by Radiation Safety & Nuclear Products, Inc. — Product Code IWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1985
Date Received
February 1, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Wire, Iridium, Radioactive
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

Other clearances by Radiation Safety & Nuclear Products, Inc.

  • K834027 — GOLD SEADS (December 27, 1983)

Other clearances for product code IWA

  • K915253 — IR-192 IMPLANT, MODIFICATION (February 27, 1992)
  • K894409 — CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD (September 29, 1989)
  • K874895 — IR-192 IMPLANT (February 25, 1988)
  • K844248 — IR-192 IMPLANT (April 10, 1985)
  • K850726 — WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD (March 26, 1985)
  • K850163 — IRIDIUM 192 WIRES (March 26, 1985)
  • K771878 — IRIDIUM 192 WIRES & PINS (October 27, 1977)