FDA 510(k) Application Details - K221874

Device Classification Name	More FDA Info for this Device
510(K) Number	K221874
Device Name	Altis Single Incision Sling System
Applicant	Coloplast A/S 1601 West River Road North Minneapolis, MN 55411 US Other 510(k) Applications for this Company
Contact	Gayatri Ghadge Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PAH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/28/2022
Decision Date	02/15/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review