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510(k) K894409

CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD by Amersham Corp. — Product Code IWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1989
Date Received
July 17, 1989
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

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  • K904666 — AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 (November 2, 1990)
  • K902760 — AMERSHAM TSH CONTROL SERA (July 27, 1990)
  • K901848 — GADOLINIUM-153 BONE DENSITOMETER SOURCES (July 9, 1990)
  • K901854 — GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412) (July 9, 1990)
  • K901832 — GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415 (July 9, 1990)
  • K901857 — GADOLINIUM-153 BONE DENSITOMETER (GDC.10413) (July 9, 1990)
  • K896270 — AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 (December 12, 1989)

Other clearances for product code IWA

  • K915253 — IR-192 IMPLANT, MODIFICATION (February 27, 1992)
  • K874895 — IR-192 IMPLANT (February 25, 1988)
  • K850382 — IRIDIUM SEEDS (August 15, 1985)
  • K844248 — IR-192 IMPLANT (April 10, 1985)
  • K850163 — IRIDIUM 192 WIRES (March 26, 1985)
  • K850726 — WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD (March 26, 1985)
  • K771878 — IRIDIUM 192 WIRES & PINS (October 27, 1977)