FDA 510(k) Application Details - K170203

Device Classification Name	System, Applicator, Radionuclide, Remote-Controlled   More FDA Info for this Device
510(K) Number	K170203
Device Name	System, Applicator, Radionuclide, Remote-Controlled
Applicant	Kobold, LLC 23403 E. Mission Ave. Suite 220E Liberty Lake, WA 99019 US Other 510(k) Applications for this Company
Contact	Deanna Hughes 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	01/23/2017
Decision Date	06/01/2017
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