Cleared Traditional

DISPOSABLE INFUSION SET

K090012 · Shan Dong Wei Gao Group Medical Polymer Products · General Hospital

Jun 2009

Decision

160d

Days

Class 2

Risk

About This 510(k) Submission

K090012 is an FDA 510(k) clearance for the DISPOSABLE 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 June 11, 2009, 160 days after receiving the submission on January 2, 2009. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K090012 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 02, 2009
Decision Date	June 11, 2009
Days to Decision	160 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF