FDA 510(k) Application Details - K193390

Device Classification Name	More FDA Info for this Device
510(K) Number	K193390
Device Name	CS Model+
Applicant	Trophy 4 Rue F. Pelloutier Croissy-Beaubourg 77435 FR Other 510(k) Applications for this Company
Contact	Marie-Pierre Labat-Camy 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	12/06/2019
Decision Date	04/02/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review