Cleared Traditional

STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)

K972728 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
Jul 1998
Decision
359d
Days
Class 2
Risk

About This 510(k) Submission

K972728 is an FDA 510(k) clearance for the STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS), 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 July 15, 1998, 359 days after receiving the submission on July 21, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K972728 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 1997
Decision Date July 15, 1998
Days to Decision 359 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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