Cleared Special

AUTOJECT 2 FOR GLASSY SYRINGE

K122837 · Owen Mumford, Ltd. · General Hospital
Oct 2012
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K122837 is an FDA 510(k) clearance for the AUTOJECT 2 FOR GLASSY SYRINGE, a Introducer, Syringe Needle (Class II — Special Controls, product code KZH), submitted by Owen Mumford, Ltd. (Woodstock, Oxfordshire, GB). The FDA issued a Cleared decision on October 15, 2012, 28 days after receiving the submission on September 17, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6920.

Submission Details

510(k) Number K122837 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2012
Decision Date October 15, 2012
Days to Decision 28 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KZH — Introducer, Syringe Needle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6920

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