FDA 510(k) Application Details - K190296

Device Classification Name	Source, Brachytherapy, Radionuclide   More FDA Info for this Device
510(K) Number	K190296
Device Name	Source, Brachytherapy, Radionuclide
Applicant	GT Medical Technologies 1809 S Holbrook Drive, Suite 107 Tempe, AZ 85281 US Other 510(k) Applications for this Company
Contact	Jessica Newhard 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	02/11/2019
Decision Date	03/13/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review