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510(k) K090459

DISPOSABLE TPE INFUSION SET by Shan Dong Wei Gao Group Medical Polymer Products — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2009
Date Received
February 23, 2009
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

Other clearances by Shan Dong Wei Gao Group Medical Polymer Products

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  • K083349 — BLOOD TRANSFUSION SET (April 10, 2009)

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