Cleared Traditional

BECTON DICKINSON BLUNT PLASTIC CANNULA

K964654 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
Apr 1997
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K964654 is an FDA 510(k) clearance for the BECTON DICKINSON BLUNT PLASTIC CANNULA, 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 April 2, 1997, 133 days after receiving the submission on November 20, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K964654 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 1996
Decision Date April 02, 1997
Days to Decision 133 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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