\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR

Accessories, Blood Circuit, Hemodialysis

FRESENIUS MEDICAL CARE

The following data is part of a premarket notification filed by Fresenius Medical Care with the FDA for \resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow Reserving Connector.

Pre-market Notification Details

Device IDK022536
510k NumberK022536
Device Name:\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR
ClassificationAccessories, Blood Circuit, Hemodialysis
Applicant FRESENIUS MEDICAL CARE 95 HAYDEN AVE. Lexington,  MA  02420
ContactArt Eilinsfeld
CorrespondentArt Eilinsfeld
FRESENIUS MEDICAL CARE 95 HAYDEN AVE. Lexington,  MA  02420
Product CodeKOC  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-08-01
Decision Date2002-10-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10840861100313 K022536 000

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