FDA 510(k) Application Details - K150828

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K150828
Device Name	Condom
Applicant	O-RING Products LLC 4012 Grand Manor Court, #208 Raleigh, NC 27612 US Other 510(k) Applications for this Company
Contact	William Mistler 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	03/30/2015
Decision Date	12/18/2015
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