FDA 510(k) Application Details - K161396

Device Classification Name	Source, Brachytherapy, Radionuclide   More FDA Info for this Device
510(K) Number	K161396
Device Name	Source, Brachytherapy, Radionuclide
Applicant	Source Production and Equipment Co.,Inc. 113 Teal Street Saint Rose, LA 70087 US Other 510(k) Applications for this Company
Contact	Kelley Richardt 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	05/19/2016
Decision Date	08/17/2016
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