FDA 510(k) Application Details - K241617

Device Classification Name	Condom, Synthetic   More FDA Info for this Device
510(K) Number	K241617
Device Name	Condom, Synthetic
Applicant	RB Health (US) LLC 399 Interpace Parkway Parsippany, NJ 07054 US Other 510(k) Applications for this Company
Contact	Matthew Pleus Other 510(k) Applications for this Contact
Regulation Number	884.5300   More FDA Info for this Regulation Number
Classification Product Code	MOL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/05/2024
Decision Date	02/28/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review