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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 K222271
Device Name Verisafe Safety sterile needles
Applicant
Promisemed Hangzhou Meditech Co., Ltd.
# 1388 Cangxing St.
Cangqian Community, Yuhang District
Hangzhou City,  CN 311121
Applicant Contact Zearou Yang
Correspondent
Promisemed Hangzhou Meditech Co., Ltd.
# 1388 Cangxing St.
Cangqian Community, Yuhang District
Hangzhou City,  CN 311121
Correspondent Contact Zearou Yang
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/29/2022
Decision Date 02/15/2023
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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