Cleared Traditional

TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES

K053413 · Terumo Europe N.V. · General Hospital
Apr 2006
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K053413 is an FDA 510(k) clearance for the TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, 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 April 6, 2006, 120 days after receiving the submission on December 7, 2005. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K053413 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 2005
Decision Date April 06, 2006
Days to Decision 120 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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