Multiple Tubing Segment Set With Stay Safe PIN Connectors, Stay Safe Drain 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 Multiple Tubing Segment Set With Stay Safe Pin Connectors, Stay Safe Drain Set.

Pre-market Notification Details

Device IDK173651
510k NumberK173651
Device Name:Multiple Tubing Segment Set With Stay Safe PIN Connectors, Stay Safe Drain 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 Received2017-11-28
Decision Date2018-02-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10840861100696 K173651 000
10840861100580 K173651 000

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