FDA 510(k) Application Details - K141701

Device Classification Name	Source, Brachytherapy, Radionuclide   More FDA Info for this Device
510(K) Number	K141701
Device Name	Source, Brachytherapy, Radionuclide
Applicant	ISOAID, L.L.C. 7824 CLARK MOODY BLVD. PORT RICHEY, FL 34668 US Other 510(k) Applications for this Company
Contact	MARY ANN GREENAWALT 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	06/24/2014
Decision Date	12/05/2014
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