FDA 510(k) Application Details - K182438

Device Classification Name	Condom, Synthetic   More FDA Info for this Device
510(K) Number	K182438
Device Name	Condom, Synthetic
Applicant	Sxwell Usa LLC 111 Wood Avenue South 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	09/07/2018
Decision Date	12/06/2018
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