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510(k) K091154

UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330, by Nucletron Corporation — Product Code JAQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 18, 2009
Date Received: April 21, 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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