FDA 510(k) Application Details - K190049

Device Classification Name	More FDA Info for this Device
510(K) Number	K190049
Device Name	Sim&Size
Applicant	Sim&Cure 1682 Rue de la Valsiere Grabels 34790 FR Other 510(k) Applications for this Company
Contact	Krishna Mahadea Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2019
Decision Date	09/17/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review