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510(k) K973363

NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633 by Ml Strategies, Inc. — Product Code IWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1998
Date Received
September 8, 1997
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 Ml Strategies, Inc.

  • K983401 — FRAMEWAVE WEB (December 15, 1998)
  • K972271 — NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL (October 28, 1997)
  • K950354 — HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF PREGNA (July 19, 1995)

Other clearances for product code IWI

  • K940632 — I-125 RAPID STRAND (September 2, 1994)
  • K912170 — RADIOACTIVE IODINE-125 SOURCES (August 9, 1991)
  • 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)