Cleared Traditional

K061092 - BAXTER DUPLOSPRAY MIS APPLICATOR
(FDA 510(k) Clearance)

K061092 · Micromedics, Inc. · General Hospital

Sep 2006

Decision

147d

Days

Class 2

Risk

K061092 is an FDA 510(k) clearance for the BAXTER DUPLOSPRAY MIS APPLICATOR, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on September 13, 2006, 147 days after receiving the submission on April 19, 2006. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K061092 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 19, 2006
Decision Date	September 13, 2006
Days to Decision	147 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement