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510(k) K091598

LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS by Nucletron Corp. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2009
Date Received
June 3, 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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