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510(k) K083349

BLOOD TRANSFUSION SET by Shan Dong Wei Gao Group Medical Polymer Products — Product Code BRZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2009
Date Received
November 13, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Blood Transfusion
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Shan Dong Wei Gao Group Medical Polymer Products

  • K090459 — DISPOSABLE TPE INFUSION SET (October 13, 2009)
  • K090012 — DISPOSABLE INFUSION SET (June 11, 2009)

Other clearances for product code BRZ

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  • K210335 — Blood Administration Set (June 10, 2021)
  • K132905 — 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER (October 4, 2013)
  • K073339 — BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SI (March 3, 2008)
  • K041496 — PENTATRASFU BLOOD TRANSFUSION SETS (June 30, 2005)
  • K050805 — 30 ML OR 60 ML PEDI-SYRINGE FILTER (June 20, 2005)
  • K050115 — BLOOD HAND PUMP ADMINISTRATION SET (April 1, 2005)
  • K023039 — BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 (November 7, 2002)
  • K000685 — CHARTER MEDICAL NEONATAL SYRINGE SET (August 15, 2000)
  • K993120 — MODIFIED BLOOD RECIPIENT SET (November 17, 1999)