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510(k) K091117

ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA by Isoaid, LLC — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2009
Date Received
April 17, 2009
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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  • K011205 — ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 (July 10, 2001)

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