FDA 510(k) Application Details - K163206

Device Classification Name	Source, Brachytherapy, Radionuclide   More FDA Info for this Device
510(K) Number	K163206
Device Name	Source, Brachytherapy, Radionuclide
Applicant	Salutaris Medical Devices, Inc. 4330 N Campbell Ave, Suite 266 Tucson, AZ 85718 US Other 510(k) Applications for this Company
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 Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2016
Decision Date	12/15/2016
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