FDA 510(k) Application Details - K171172

Device Classification Name	Condom, Synthetic   More FDA Info for this Device
510(K) Number	K171172
Device Name	Condom, Synthetic
Applicant	Ansell Healthcare Products LLC. 111 Wood Avenue South, Suite 210 Iselin, NJ 08830 US Other 510(k) Applications for this Company
Contact	Robert Mahler 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	04/21/2017
Decision Date	08/02/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review