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FDA 510(k) Application Details - K223465
Device Classification Name
Source, Brachytherapy, Radionuclide
More FDA Info for this Device
510(K) Number
K223465
Device Name
Source, Brachytherapy, Radionuclide
Applicant
Radiance Therapeutics Inc.
7440 N Oracle Rd., Building #1
Tucson, AZ 85718 US
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Contact
Laurence Marsteller
Other 510(k) Applications for this Contact
Regulation Number
892.5730
More FDA Info for this Regulation Number
Classification Product Code
KXK
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More FDA Info for this Product Code
Date Received
11/17/2022
Decision Date
01/11/2023
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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