Liberty Cycler Set

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 Liberty Cycler Set.

Pre-market Notification Details

Device IDK173718
510k NumberK173718
Device Name:Liberty Cycler Set
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 Received2017-12-05
Decision Date2018-05-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10840861102324 K173718 000
10840861102317 K173718 000
10840861102300 K173718 000
10840861102713 K173718 000
10840861102706 K173718 000

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