Cleared Traditional

BLOOD TRANSFUSION SET

K083349 · Shan Dong Wei Gao Group Medical Polymer Products · General Hospital

Apr 2009

Decision

148d

Days

Class 2

Risk

About This 510(k) Submission

K083349 is an FDA 510(k) clearance for the BLOOD TRANSFUSION SET, a Set, Blood Transfusion (Class II — Special Controls, product code BRZ), submitted by Shan Dong Wei Gao Group Medical Polymer Products (Shan Nan Er Rd., Shanghai, CN). The FDA issued a Cleared decision on April 10, 2009, 148 days after receiving the submission on November 13, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K083349 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 2008
Decision Date	April 10, 2009
Days to Decision	148 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF