Cleared Special

MODIFICATION TO AUTOFUSER

K090300 · Ace Medical Us, LLC · General Hospital

Apr 2009

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K090300 is an FDA 510(k) clearance for the MODIFICATION TO AUTOFUSER, a Pump, Infusion, Elastomeric (Class II — Special Controls, product code MEB), submitted by Ace Medical Us, LLC (Powell, US). The FDA issued a Cleared decision on April 30, 2009, 83 days after receiving the submission on February 6, 2009. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K090300 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 06, 2009
Decision Date	April 30, 2009
Days to Decision	83 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Summary PDF