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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 K031279
Device Name SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
Applicant
Terumo Medical Products Hangzhou Co., Ltd.
125 Blue Ball Rd.
Elkton,  MD  21921
Applicant Contact KAZUHITO INOUE
Correspondent
Terumo Medical Products Hangzhou Co., Ltd.
125 Blue Ball Rd.
Elkton,  MD  21921
Correspondent Contact KAZUHITO INOUE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/22/2003
Decision Date 05/30/2003
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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