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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Coring (Huber) Needle
510(k) Number K243332
Device Name Promisemed Safety Huber 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
PTI  
Date Received10/24/2024
Decision Date 03/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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