Cleared Traditional

BECTON DICKINSON TWINPAK

K974006 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
Jan 1998
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K974006 is an FDA 510(k) clearance for the BECTON DICKINSON TWINPAK, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on January 22, 1998, 93 days after receiving the submission on October 21, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K974006 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1997
Decision Date January 22, 1998
Days to Decision 93 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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