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510(k) K973848

IBU, INTEGRATED BRACHY THERAPY UNIT by Nucletron Corp. — Product Code KPQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1998
Date Received
October 8, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Simulation, Radiation Therapy
Device Class
Class II
Regulation Number
892.5840
Review Panel
RA
Submission Type

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