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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 K211293
Device Name Safety Winged Blood Collection Sets
Applicant
Promisemed Hangzhou Meditech Co., Ltd.
No. 12 Longtan Road, Cangqian Street
Yuhang District
Hangzhou City,  CN 311121
Applicant Contact Zearou Yang
Correspondent
MedTech Review, LLC
257 Garnet Garden Street
Henderson,  NV  89015
Correspondent Contact John Beasley
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Code
FPA  
Date Received04/26/2021
Decision Date 06/25/2021
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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