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510(k) K940119

ROYAL MARSDEN GOLD GRAIN GUN by Best Industries — Product Code IWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1994
Date Received
January 10, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shield, Eye, Radiological
Device Class
Class I
Regulation Number
892.6500
Review Panel
RA
Submission Type

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  • K932242 — RADIOACTIVE SAMARIUM 145 SEEDS/SOURCES #2341-2345 (July 27, 1993)
  • K924290 — BEST INDUSTRIES CARTRIDGE & GUN (June 4, 1993)
  • K924261 — RADIOACTIVE CESIUM-131 SEEDS/SOURCES (June 4, 1993)
  • K930570 — RADIOACTIVE PALLADIUM 103 SEEDS/SOURCES (June 4, 1993)
  • K912170 — RADIOACTIVE IODINE-125 SOURCES (August 9, 1991)
  • K910862 — VARIOUS TEMPLATE APPLICATORS (April 18, 1991)

Other clearances for product code IWS

  • K945515 — COATED TUNGSTEN EYESHIELD (June 19, 1995)
  • K943011 — TUNGSTEN EYESHIELD (December 23, 1994)
  • K934459 — MED-GENESIS PATIENT LASER EYE SHIELD (February 22, 1994)
  • K934362 — NUCLEAR ASSOCIATES GLASSERS (November 12, 1993)
  • K920540 — RADIOLOGICAL PROTECTIVE EYE SHIELD (May 28, 1992)