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510(k) K141701

I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] by Isoaid, LLC — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2014
Date Received
June 24, 2014
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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  • K033770 — ISOAID ADVANTAGE PD-103, MODEL IAPD-103A (April 8, 2004)
  • K011205 — ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 (July 10, 2001)

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