FDA 510(k) Application Details - K222798

Device Classification Name	Cannula, Manipulator/Injector, Uterine   More FDA Info for this Device
510(K) Number	K222798
Device Name	Cannula, Manipulator/Injector, Uterine
Applicant	Rejoni, Inc. 201 Burlington Road Bedford, MA 01730 US Other 510(k) Applications for this Company
Contact	Brian Bergeron 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	09/16/2022
Decision Date	12/16/2022
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