FDA 510(k), K212522, Lilliput APD System

NOTE: The original was a HEAVILY REDACTED 32,276 page document. Most of the fully redacted pages were removed and now there are 2,117 pages. 

510(K) Number: K212522
Device Name: Lilliput APD System
Manufacturer: Denise Oppermann
Device Classification Name: System, Peritoneal, Automatic Delivery
Regulation Number: FKX
Classification Product Code: KXA
Date Received: 08/11/2021
Decision Date: 04/15/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology