FDA 510(k) Application Details - K243584

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K243584
Device Name	Condom
Applicant	Okamoto USA, Inc. 3130 West Monroe Street Sandusky, OH 44870 US Other 510(k) Applications for this Company
Contact	Kenji Komatsu 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	11/20/2024
Decision Date	02/18/2025
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