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510(k) K032372

NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007 by Nucletron Corporation — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2003
Date Received
August 1, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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