Cleared Abbreviated

ICU MEDICAL SINGLE-USE SYRINGE

K070856 · Icu Medical, Inc. · General Hospital
Oct 2007
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K070856 is an FDA 510(k) clearance for the ICU MEDICAL SINGLE-USE SYRINGE, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 5, 2007, 191 days after receiving the submission on March 28, 2007. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K070856 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2007
Decision Date October 05, 2007
Days to Decision 191 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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