Medwell Technology Ltd Syringes, Various Sizes

Syringe, Piston

Medwell Technology Ltd

The following data is part of a premarket notification filed by Medwell Technology Ltd with the FDA for Medwell Technology Ltd Syringes, Various Sizes.

Pre-market Notification Details

Device IDK212764
510k NumberK212764
Device Name:Medwell Technology Ltd Syringes, Various Sizes
ClassificationSyringe, Piston
Applicant Medwell Technology Ltd 8th Building, Pujing, Fumin Industry Zone, DaLang Town Dongguan City,  CN 523770
ContactAndy Song
CorrespondentJonathan Gilbert
Medwell Technology Ltd 1641 Jeurissen Lane Chanhassen,  MN  55317
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-31
Decision Date2022-11-04

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