LUER LOCKING ADAPTER(MATERIAL CHANGE)

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

QUINTON, INC.

The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Luer Locking Adapter(material Change).

Pre-market Notification Details

Device IDK840815
510k NumberK840815
Device Name:LUER LOCKING ADAPTER(MATERIAL CHANGE)
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant QUINTON, INC. 2121 TERRY AVE. Seatle,  WA  98121
ContactDan Roper
CorrespondentDan Roper
QUINTON, INC. 2121 TERRY AVE. Seatle,  WA  98121
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-02-27
Decision Date1984-11-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521003979 K840815 000

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