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FDA 510(k) Application Details - K133922
Device Classification Name
System, Applicator, Radionuclide, Remote-Controlled
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510(K) Number
K133922
Device Name
System, Applicator, Radionuclide, Remote-Controlled
Applicant
GC MEDTECH, LLC
3924 CASCADE BEACH ROAD
LUTSEN, MN 55612 US
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Contact
GREGORY MATHISON
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Regulation Number
892.5700
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Classification Product Code
JAQ
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More FDA Info for this Product Code
Date Received
12/23/2013
Decision Date
04/18/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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