FDA 510(k) Application Details - K220035

Device Classification Name	Dilator, Vaginal   More FDA Info for this Device
510(K) Number	K220035
Device Name	Dilator, Vaginal
Applicant	Materna Medical 2495 Hospital Drive, Suite 300 Mountain View, CA 94040 US Other 510(k) Applications for this Company
Contact	Kelly Ashfield Other 510(k) Applications for this Contact
Regulation Number	884.3900   More FDA Info for this Regulation Number
Classification Product Code	HDX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/05/2022
Decision Date	02/27/2023
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