Blood Transfusion Set

FDA 510(k) K083349 · Shan Dong Wei Gao Group Medical Polymer Products

Substantially Equivalent

510(k) numberK083349

Submission

Device name
Blood Transfusion Set
Applicant
Shan Dong Wei Gao Group Medical Polymer Products
Shan Nan Er Rd., Shanghai, CN
Received
November 13, 2008
Decision date
April 10, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BRZ – Set, Blood Transfusion
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Specialty
General Hospital

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Questions and answers

When was Blood Transfusion Set cleared by the FDA?

Blood Transfusion Set (K083349) received a 510(k) decision of Substantially Equivalent on April 10, 2009, 148 days after the submission was received.

What is the product code of K083349?

The FDA product code is BRZ – Set, Blood Transfusion, a Class II (moderate risk) device regulated under 21 CFR 880.5440.