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510(k) K991526

ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 by Imagyn Medical Technologies, Inc. — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1999
Date Received
May 3, 1999
Clearance Type
Special
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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  • K974173 — ERECAID SYSTEM/STAY EREC SYSTEM (February 25, 1998)

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