Cleared Traditional

BECTON DICKINSON SYRINGE

K980987 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
Jun 1998
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K980987 is an FDA 510(k) clearance for the BECTON DICKINSON SYRINGE, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on June 11, 1998, 86 days after receiving the submission on March 17, 1998. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K980987 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 1998
Decision Date June 11, 1998
Days to Decision 86 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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