Cleared Traditional

ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)

K943740 · Premium Plastics, Inc. · General Hospital
Dec 1994
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K943740 is an FDA 510(k) clearance for the ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY), a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Premium Plastics, Inc. (Chicago, US). The FDA issued a Cleared decision on December 14, 1994, 134 days after receiving the submission on August 2, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K943740 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 1994
Decision Date December 14, 1994
Days to Decision 134 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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