Cleared Traditional

TERUMO SYRINGE WITH/WITHOUT NEEDLE

K083514 · Terumo Europe N.V. · General Hospital
May 2009
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K083514 is an FDA 510(k) clearance for the TERUMO SYRINGE WITH/WITHOUT NEEDLE, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Terumo Europe N.V. (Leuven, BE). The FDA issued a Cleared decision on May 22, 2009, 177 days after receiving the submission on November 26, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K083514 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 2008
Decision Date May 22, 2009
Days to Decision 177 days
Submission Type Traditional
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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