FDA 510(k) Application Details - K202403

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K202403
Device Name	Condom
Applicant	TTK Healthcare Limited 12, K P Natham Road, Thiruvandar Koil, Puducherry 605102 IN Other 510(k) Applications for this Company
Contact	Daniel J. S. 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	08/21/2020
Decision Date	04/15/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review