Cleared Traditional

BECTON DICKINSON SYRINGE

K992734 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
Oct 1999
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K992734 is an FDA 510(k) clearance for the BECTON DICKINSON SYRINGE, a Syringe, Antistick (Class II — Special Controls, product code MEG), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on October 1, 1999, 49 days after receiving the submission on August 13, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K992734 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 1999
Decision Date October 01, 1999
Days to Decision 49 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MEG — Syringe, Antistick
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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