FDA 510(k) Application Details - K202542

Device Classification Name	Stent, Vaginal   More FDA Info for this Device
510(K) Number	K202542
Device Name	Stent, Vaginal
Applicant	PMT Corporation 1500 Park Road Chanhassen, MN 55317 US Other 510(k) Applications for this Company
Contact	Matt Cree Other 510(k) Applications for this Contact
Regulation Number	884.3900   More FDA Info for this Regulation Number
Classification Product Code	KXP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/02/2020
Decision Date	09/30/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review