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510(k) K073107

VALENCIA SKIN APPLICATOR SET, MODEL: 189.701 by Nucletron Corporation — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2007
Date Received
November 2, 2007
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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