FDA 510(k) Application Details - K191416

Device Classification Name	More FDA Info for this Device
510(K) Number	K191416
Device Name	Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack
Applicant	Caldera Medical, Inc. 5171 Clareton Drive Agoura Hills, CA 91301 US Other 510(k) Applications for this Company
Contact	Vicki Gail 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	05/28/2019
Decision Date	02/07/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review