FDA 510(k) Application Details - K211152

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K211152
Device Name	Condom
Applicant	RB Health (US) LLC 399 Interpace Parkway Parsippany, NJ 07054 US Other 510(k) Applications for this Company
Contact	Kyle Prince Other 510(k) Applications for this Contact
Regulation Number	884.5300   More FDA Info for this Regulation Number
Classification Product Code	HIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/2021
Decision Date	05/11/2022
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