FDA 510(k) Application Details - K203727

Device Classification Name	Barrier,Std,Oral Sex   More FDA Info for this Device
510(K) Number	K203727
Device Name	Barrier,Std,Oral Sex
Applicant	Pamco Distributing Inc. 231 Arnold Street Kitchener N2H 6E8 CA Other 510(k) Applications for this Company
Contact	Annette Maclean 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	12/21/2020
Decision Date	08/05/2021
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