FDA 510(k) Application Details - K200221

Device Classification Name	System, Applicator, Radionuclide, Remote-Controlled   More FDA Info for this Device
510(K) Number	K200221
Device Name	System, Applicator, Radionuclide, Remote-Controlled
Applicant	Mick Radio-Nuclear Instruments, Inc. 521 Homestead Avenue Mount Vernon, NY 10550 US Other 510(k) Applications for this Company
Contact	James Hurlman 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	01/29/2020
Decision Date	02/28/2020
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