FDA 510(k) Application Details - K202267

Device Classification Name	Source, Brachytherapy, Radionuclide   More FDA Info for this Device
510(K) Number	K202267
Device Name	Source, Brachytherapy, Radionuclide
Applicant	Isoray Medical, Inc. 350 Hills St, Suite 106 Richland, WA 99354 US Other 510(k) Applications for this Company
Contact	Leslie White Other 510(k) Applications for this Contact
Regulation Number	892.5730   More FDA Info for this Regulation Number
Classification Product Code	KXK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/11/2020
Decision Date	12/31/2020
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