FDA 510(k) Application Details - K161195

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K161195
Device Name	Condom
Applicant	M3 GLOBAL ENTERPRISES, LLC 70 BIRCH ALLEY, SUITE 240 BUILDING B BEAVERCREEK, OH 45440 US Other 510(k) Applications for this Company
Contact	NEIL MEHTA 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	04/27/2016
Decision Date	08/25/2016
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