HEMODIALYSIS BLOOD LINES

Accessories, Blood Circuit, Hemodialysis

GAINOR MEDICAL EUROPE, LTD.

The following data is part of a premarket notification filed by Gainor Medical Europe, Ltd. with the FDA for Hemodialysis Blood Lines.

Pre-market Notification Details

Device IDK900306
510k NumberK900306
Device Name:HEMODIALYSIS BLOOD LINES
ClassificationAccessories, Blood Circuit, Hemodialysis
Applicant GAINOR MEDICAL EUROPE, LTD. P.O. BOX 353 Mcdonough,  GA  30253 -0353
ContactMark Gainor
CorrespondentMark Gainor
GAINOR MEDICAL EUROPE, LTD. P.O. BOX 353 Mcdonough,  GA  30253 -0353
Product CodeKOC  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-01-21
Decision Date1990-04-20

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