FDA 510(k) Application Details - K250629

Device Classification Name	Lubricant, Patient, Vaginal, Latex Compatible   More FDA Info for this Device
510(K) Number	K250629
Device Name	Lubricant, Patient, Vaginal, Latex Compatible
Applicant	Hathor Professional Skincare Ltd. 2618 Roseberry Ave Victoria V8R 3T7 CA Other 510(k) Applications for this Company
Contact	Carolyn (Mellta) Swift Other 510(k) Applications for this Contact
Regulation Number	884.5300   More FDA Info for this Regulation Number
Classification Product Code	NUC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/03/2025
Decision Date	05/02/2025
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