Lilliput APD System

System, Peritoneal, Automatic Delivery

Fresenius Medical Care Renal Therapies Group, LLC

The following data is part of a premarket notification filed by Fresenius Medical Care Renal Therapies Group, Llc with the FDA for Lilliput Apd System.

Pre-market Notification Details

Device IDK212522
510k NumberK212522
Device Name:Lilliput APD System
ClassificationSystem, Peritoneal, Automatic Delivery
Applicant Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham,  MA  02451
ContactDenise Oppermann
CorrespondentDenise Oppermann
Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham,  MA  02451
Product CodeFKX  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-11
Decision Date2022-04-15

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