Cleared Special

MONOJECT INSULIN SYRINGE

K033373 · Tyco Healthcare · General Hospital
Nov 2003
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K033373 is an FDA 510(k) clearance for the MONOJECT INSULIN SYRINGE, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Tyco Healthcare (Mansfield, US). The FDA issued a Cleared decision on November 13, 2003, 22 days after receiving the submission on October 22, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K033373 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 2003
Decision Date November 13, 2003
Days to Decision 22 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMI — Needle, Hypodermic, Single Lumen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

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