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FDA 510(k) Application Details - K142439
Device Classification Name
System, Applicator, Radionuclide, Remote-Controlled
More FDA Info for this Device
510(K) Number
K142439
Device Name
System, Applicator, Radionuclide, Remote-Controlled
Applicant
Nucletron BV
Waardgelder 1
Veenendaal 3905 TH NL
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Contact
Rudolf Vos
Other 510(k) Applications for this Contact
Regulation Number
892.5700
More FDA Info for this Regulation Number
Classification Product Code
JAQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/29/2014
Decision Date
03/10/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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