FDA 510(k) Application Details - K212037

Device Classification Name	Barrier,Std,Oral Sex   More FDA Info for this Device
510(K) Number	K212037
Device Name	Barrier,Std,Oral Sex
Applicant	Sanctuary Health Sdn. Bhd. No. 16, Persiaran Perindustrian Kanthan 1, Kawasan Perindustrian Kanthan Chemor 31200 MY Other 510(k) Applications for this Company
Contact	Sumethi Selavaraju Other 510(k) Applications for this Contact
Regulation Number	884.5300   More FDA Info for this Regulation Number
Classification Product Code	MSC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/30/2021
Decision Date	03/28/2022
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