Cycler Drain Bag Set

Set, Administration, For Peritoneal Dialysis, Disposable

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 Cycler Drain Bag Set.

Pre-market Notification Details

Device IDK173363
510k NumberK173363
Device Name:Cycler Drain Bag Set
ClassificationSet, Administration, For Peritoneal Dialysis, Disposable
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 CodeKDJ  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-26
Decision Date2018-01-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840861102037 K173363 000

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