Cleared Traditional

DISPOSABLE TPE INFUSION SET

K090459 · Shan Dong Wei Gao Group Medical Polymer Products · General Hospital

Oct 2009

Decision

232d

Days

Class 2

Risk

About This 510(k) Submission

K090459 is an FDA 510(k) clearance for the DISPOSABLE TPE INFUSION SET, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Shan Dong Wei Gao Group Medical Polymer Products (Shan Nan Er Rd., Shanghai, CN). The FDA issued a Cleared decision on October 13, 2009, 232 days after receiving the submission on February 23, 2009. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K090459 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 23, 2009
Decision Date	October 13, 2009
Days to Decision	232 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF