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510(k) K844248

IR-192 IMPLANT by Rads S.L., Inc. — Product Code IWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1985
Date Received
November 2, 1984
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 Rads S.L., Inc.

  • K903465 — IR-192 IMPLANT (October 12, 1990)
  • K874895 — IR-192 IMPLANT (February 25, 1988)

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)
  • K850382 — IRIDIUM SEEDS (August 15, 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)