Cleared Special

29G AND 30G K-PACK II NEEDLE

K062608 · Terumo Europe N.V. · General Hospital
Sep 2006
Decision
10d
Days
Class 2
Risk

About This 510(k) Submission

K062608 is an FDA 510(k) clearance for the 29G AND 30G K-PACK II NEEDLE, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Terumo Europe N.V. (Leuven, BE). The FDA issued a Cleared decision on September 15, 2006, 10 days after receiving the submission on September 5, 2006. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K062608 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 2006
Decision Date September 15, 2006
Days to Decision 10 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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