Cleared Special

K-PACK II NEEDLE - 29G THIN WALL

K082820 · Terumo Europe N.V. · General Hospital
Oct 2008
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K082820 is an FDA 510(k) clearance for the K-PACK II NEEDLE - 29G THIN WALL, 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 October 23, 2008, 28 days after receiving the submission on September 25, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K082820 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2008
Decision Date October 23, 2008
Days to Decision 28 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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