FDA 510(k) Application Details - K201067

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K201067
Device Name	Condom
Applicant	CUPID Limited A-68, M.I.D.C. (Malegaon), Sinnar Nashik 422113 IN Other 510(k) Applications for this Company
Contact	Durgesh Garg 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	04/22/2020
Decision Date	08/07/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review