NeedleSmart Professional (NS Pro)

Sharps Needle Destruction Device

NeedleSmart Limited

The following data is part of a premarket notification filed by Needlesmart Limited with the FDA for Needlesmart Professional (ns Pro).

Pre-market Notification Details

Device IDK202073
510k NumberK202073
Device Name:NeedleSmart Professional (NS Pro)
ClassificationSharps Needle Destruction Device
Applicant NeedleSmart Limited Suite 2B, Stanley Grange Business Park, Ormskirk Road, Knowsley, Prescot,  GB L34 5nb
ContactTom Baker
CorrespondentTom Baker
NeedleSmart Limited Suite 2B, Stanley Grange Business Park, Ormskirk Road, Knowsley, Prescot,  GB L34 5nb
Product CodeMTV  
CFR Regulation Number880.6210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-27
Decision Date2021-03-25

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