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510(k) K852023

CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41 by Syncor Intl. Corp. — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1985
Date Received
May 8, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Brachytherapy, Radionuclide
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

Other clearances by Syncor Intl. Corp.

  • K945825 — SECURE SAFETY INSERT (April 10, 1995)
  • K851828 — IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C (September 19, 1985)
  • K850433 — CESIUM 137 ENDOMETRIAL SOURCE (August 21, 1985)
  • K852665 — SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY (August 13, 1985)
  • K851033 — SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT (June 21, 1985)
  • K844735 — PTH-RIA (April 29, 1985)
  • K850726 — WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD (March 26, 1985)
  • K850434 — CS137 SEALED SOURCES (March 26, 1985)
  • K850163 — IRIDIUM 192 WIRES (March 26, 1985)
  • K850208 — FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS (March 26, 1985)

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