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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K221411
Device Name Surflo Winged Infusion Set
Applicant
Terumo Medical Products (Hangzhou) Co., Ltd.
M4-9-5, Economic & Technological Development Zone
Hangzhou,  CN 310018
Applicant Contact Brian Byrd
Correspondent
Terumo Medical Corporation
265 Davidson Avenue, Suite 320
Somerset,  NJ  08873
Correspondent Contact Brian Byrd
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/16/2022
Decision Date 06/23/2023
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
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