NEEDLE, DIALYSIS

Needle, Fistula

GAINOR MEDICAL EUROPE, LTD.

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

Pre-market Notification Details

Device IDK902564
510k NumberK902564
Device Name:NEEDLE, DIALYSIS
ClassificationNeedle, Fistula
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 CodeFIE  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-06-11
Decision Date1991-03-01

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