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FDA 510(k) Application Details - K180515
Device Classification Name
Source, Brachytherapy, Radionuclide
More FDA Info for this Device
510(K) Number
K180515
Device Name
Source, Brachytherapy, Radionuclide
Applicant
Isoray Medical Inc.
350 Hills Street, Suite 106
Richland, WA 99354 US
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Contact
Bill Joy
Other 510(k) Applications for this Contact
Regulation Number
892.5730
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Classification Product Code
KXK
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More FDA Info for this Product Code
Date Received
02/27/2018
Decision Date
07/06/2018
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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