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510(k) K041715

INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001 by Nucletron Corp. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2005
Date Received
June 23, 2004
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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