FDA 510(k) Application Details - K212505

Device Classification Name	Cannula, Manipulator/Injector, Uterine   More FDA Info for this Device
510(K) Number	K212505
Device Name	Cannula, Manipulator/Injector, Uterine
Applicant	The O R Company Pty Ltd 1/32 Silkwood Place Carrum Downs 3201 AU Other 510(k) Applications for this Company
Contact	Amesha Silva Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LKF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2021
Decision Date	01/10/2022
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