FDA 510(k) Application Details - K161545

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K161545
Device Name	Condom
Applicant	CHURCH & DWIGHT CO., INC. 500 CHARLES EWING BLVD Ewing, NJ 08628 US Other 510(k) Applications for this Company
Contact	Lisa Burns 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	06/03/2016
Decision Date	08/26/2016
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