FDA 510(k) Application Details - K193003

Device Classification Name	More FDA Info for this Device
510(K) Number	K193003
Device Name	NemoCast
Applicant	Software Nemotec S.L. Juan de la Cierva Street, 66 Arroyomolinos, Madrid 28939 ES Other 510(k) Applications for this Company
Contact	Carlos Arias Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/28/2019
Decision Date	06/05/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review