FDA 510(k) Application Details - K173527

Device Classification Name	More FDA Info for this Device
510(K) Number	K173527
Device Name	Digitex Delivery Device
Applicant	Coloplast A/S 1601 West River Road North Minneapolis, MN 55411 US Other 510(k) Applications for this Company
Contact	Nikita Basandra Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PWI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/2017
Decision Date	02/12/2018
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