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510(k) K022635

KUSKE BREAST APPLICATOR SET, MODEL 189.006 by Nucletron Corporation — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2002
Date Received
August 8, 2002
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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