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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 K193273
Device Name Insulin Syringe
Applicant
Promisemed Hangzhou Meditech Co., Ltd.
# 12 Longtan Rd., Cangqian St.
Yuhang District
Hangzhou City,  CN 311121
Applicant Contact Liqing Yang
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, Block A, Zhongguan Times Sq., Liuxian Ave.,
Xili Town, Nanshan
Shenzhen,  CN 518000
Correspondent Contact Christy Young
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/26/2019
Decision Date 01/05/2021
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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