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510(k) K982421

IMAGYN 125 I SEED, MODEL IS 125 by International Isotopes, Inc. — Product Code IWG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1998
Date Received
July 13, 1998
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Seed, Isotope, Gold, Titanium, Platinum
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

Other clearances by International Isotopes, Inc.

  • K992963 — I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401 (September 21, 1999)

Other clearances for product code IWG

  • K081066 — BRACHYTHERAPY SOURCE DEVICE, MODEL 9011 (May 5, 2008)
  • K834027 — GOLD SEADS (December 27, 1983)