FDA 510(k) Application Details - K162511

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K162511
Device Name	Condom
Applicant	LELO INC. 4320 STEVENS CREEK BLVD., SUITE 205 SAN JOSE, CA 95129 US Other 510(k) Applications for this Company
Contact	PAVLE SEDIC 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	09/08/2016
Decision Date	01/13/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review