FDA 510(k) Application Details - K241748

Device Classification Name	Dilator, Vaginal   More FDA Info for this Device
510(K) Number	K241748
Device Name	Dilator, Vaginal
Applicant	Plus EV Holdings dba Intimate Rose 1419 Murray St North Kansas City, MO 64116 US Other 510(k) Applications for this Company
Contact	Aaron Wilt 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	06/18/2024
Decision Date	08/14/2024
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	Y
Expedited Review