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510(k) K080934

VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET by Nucletron Corporation — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2008
Date Received
April 2, 2008
Clearance Type
Traditional
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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