FDA 510(k) Application Details - DEN210034

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN210034
Device Name	ONE Male Condom
Applicant	Global Protection Corp. 12 Channel Street Boston, MA 02210 US Other 510(k) Applications for this Company
Contact	Davin Wedel Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QRZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/26/2021
Decision Date	02/23/2022
Decision	DENG -
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review