GAMBRO G SERIES BLOOD LINE SETS FOR HEM.

Set, Tubing, Blood, With And Without Anti-regurgitation Valve

GAMBRO, INC.

The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro G Series Blood Line Sets For Hem..

Pre-market Notification Details

Device IDK801016
510k NumberK801016
Device Name:GAMBRO G SERIES BLOOD LINE SETS FOR HEM.
ClassificationSet, Tubing, Blood, With And Without Anti-regurgitation Valve
Applicant GAMBRO, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFJK  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-04-29
Decision Date1980-05-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
37332414048915 K801016 000
37332414004690 K801016 000

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