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510(k) K011205

ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 by Isoaid — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2001
Date Received
April 19, 2001
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

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  • K091117 — ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA (September 15, 2009)
  • K033770 — ISOAID ADVANTAGE PD-103, MODEL IAPD-103A (April 8, 2004)

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  • K190839 — GammaTile (January 23, 2020)
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