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510(k) K031279

SURSHIELD SAFETY WINGED BLOOD COLLECTION SET by Terumo Medical Products Hangzhou Co., Ltd. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2003
Date Received
April 22, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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