Hypodermic Needle-Pro EDGE Safety Device

Needle, Hypodermic, Single Lumen

Smiths Medical ASD, Inc.

The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Hypodermic Needle-pro Edge Safety Device.

Pre-market Notification Details

Device IDK211634
510k NumberK211634
Device Name:Hypodermic Needle-Pro EDGE Safety Device
ClassificationNeedle, Hypodermic, Single Lumen
Applicant Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis,  MN  55442
ContactDominique Neisz
CorrespondentDominique Neisz
Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis,  MN  55442
Product CodeFMI  
Subsequent Product CodeFMF
Subsequent Product CodeMEG
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-27
Decision Date2021-08-26

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