FDA 510(k) Application Details - K192669

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K192669
Device Name	Condom
Applicant	Okamoto U.S.A., Inc. 18 King Street Stratford, CT 06615 US Other 510(k) Applications for this Company
Contact	Yu Tadano 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	09/25/2019
Decision Date	07/24/2020
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