FDA 510(k) Application Details - K221779

Device Classification Name	More FDA Info for this Device
510(K) Number	K221779
Device Name	ASEPT Peritoneal Drainage System
Applicant	PFM Medical, Inc. 1916 Palomar Oaks Way, Suite 150 Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	Jessica Jho Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2022
Decision Date	05/02/2023
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review