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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K250961
Device Name Blood collection tube holders
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 Number862.1675
Classification Product Code
JKA  
Date Received03/31/2025
Decision Date 06/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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