FDA 510(k) Application Details - K190277

Device Classification Name	Pessary, Vaginal   More FDA Info for this Device
510(K) Number	K190277
Device Name	Pessary, Vaginal
Applicant	ConTIPI Medical Ltd. 2 Alon Ha'Tavor st. Caesarea Industrial Park, POB 3135 Caesarea 3088900 IL Other 510(k) Applications for this Company
Contact	Tsvia Erlich Other 510(k) Applications for this Contact
Regulation Number	884.3575   More FDA Info for this Regulation Number
Classification Product Code	HHW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2019
Decision Date	07/08/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review