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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K212764
Device Name Medwell Technology Ltd Syringes, various sizes
Applicant
Medwell Technology, Ltd.
8th Bldg., Pujing, Fumin Industry Zone, Dalang Town
Dongguan City,  CN 523770
Applicant Contact Andy Song
Correspondent
Medwell Technology, Ltd.
1641 Jeurissen Lane
Chanhassen,  MN  55317
Correspondent Contact Jonathan Gilbert
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/31/2021
Decision Date 11/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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