Cleared Traditional

BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET

K021475 · Bd · General Hospital
Jul 2002
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K021475 is an FDA 510(k) clearance for the BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Bd (Franklin Lakes, US). The FDA issued a Cleared decision on July 19, 2002, 72 days after receiving the submission on May 8, 2002. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K021475 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2002
Decision Date July 19, 2002
Days to Decision 72 days
Submission Type Traditional
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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