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510(k) K092804

MICROSELECTRON HDR V2, MODEL 105.999 by Nucletron Corp. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2009
Date Received
September 11, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Remote-Controlled
Device Class
Class II
Regulation Number
892.5700
Review Panel
RA
Submission Type

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