Home / 510(k) Clearances / K912170

510(k) K912170

RADIOACTIVE IODINE-125 SOURCES by Best Industries — Product Code IWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1991
Date Received
May 16, 1991
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 Best Industries

  • K933410 — IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF R (December 30, 1994)
  • K940119 — ROYAL MARSDEN GOLD GRAIN GUN (December 30, 1994)
  • K940121 — IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS (December 30, 1994)
  • K932242 — RADIOACTIVE SAMARIUM 145 SEEDS/SOURCES #2341-2345 (July 27, 1993)
  • K924261 — RADIOACTIVE CESIUM-131 SEEDS/SOURCES (June 4, 1993)
  • K930570 — RADIOACTIVE PALLADIUM 103 SEEDS/SOURCES (June 4, 1993)
  • K924290 — BEST INDUSTRIES CARTRIDGE & GUN (June 4, 1993)
  • K910862 — VARIOUS TEMPLATE APPLICATORS (April 18, 1991)

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)
  • K882449 — CESIUM 137 SOURCE, MODEL CSM-40 (April 14, 1989)
  • K874787 — MODIFIED PALLADIUM SEED MODEL 100 (December 22, 1987)
  • K852542 — PALLADIUM SEED MODEL 100 (January 14, 1986)