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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K254273
Device Name Verisafe Safety Sterile Needles (SSN)
Applicant
Promisemed Hangzhou Meditech Co., Ltd.
# 1388 Cangxing St., Cangqian Community,Yuhang District
Hangzhou City,  CN 311121
Applicant Contact Zearou Yang
Correspondent
Vee Care Asia Limited
9f-25, # 188, Sec. 4, Chenggong Rd., Neihu Dist.
Taipei,  TW 114049
Correspondent Contact Wei-Shan Hsu
Regulation Number880.5570
Classification Product Code
FMI  
Date Received12/30/2025
Decision Date 04/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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