FDA 510(k) Application Details - K100767

Device Classification Name	Condom, Synthetic   More FDA Info for this Device
510(K) Number	K100767
Device Name	Condom, Synthetic
Applicant	CHURCH & DWIGHT CO., INC. 469 NORTH HARRISON STREET PRINCETON, NJ 08543 US Other 510(k) Applications for this Company
Contact	JOSEPH CICCONE 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	03/18/2010
Decision Date	04/05/2011
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