Cleared Traditional

K992734 - BECTON DICKINSON SYRINGE (FDA 510(k) Clearance)

Oct 1999
Decision
49d
Days
Class 2
Risk

K992734 is an FDA 510(k) clearance for the BECTON DICKINSON SYRINGE. This device is classified as 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 FDA review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K992734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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