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510(k) K151272

Henschke Titanium Applicator Set by Nucletron B.V. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2015
Date Received
May 13, 2015
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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