Needle, Hypodermic, Single Lumen

U-Needle B.V.

The following data is part of a premarket notification filed by U-needle B.v. with the FDA for Bella-mu.

Pre-market Notification Details

Device IDK190962
510k NumberK190962
Device Name:Bella-mu
ClassificationNeedle, Hypodermic, Single Lumen
Applicant U-Needle B.V. De Veldmaat 10 Enschede,  NL 7522 Nm
ContactGert Veldhuis
CorrespondentRobert Packard
Medical Device Academy, Inc. 345 Lincoln Hill Road Shrewsbury,  VT  05738
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
510k Review PanelGeneral Hospital
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-12
Decision Date2020-02-03

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