Cleared Traditional

THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER

K931872 · American Sterilizer Co. · General Hospital
Feb 1994
Decision
299d
Days
Class 2
Risk

About This 510(k) Submission

K931872 is an FDA 510(k) clearance for the THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER, a Sterilizer, Ethylene-oxide Gas (Class II — Special Controls, product code FLF), submitted by American Sterilizer Co. (Erie, US). The FDA issued a Cleared decision on February 7, 1994, 299 days after receiving the submission on April 14, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6860.

Submission Details

510(k) Number K931872 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 1993
Decision Date February 07, 1994
Days to Decision 299 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FLF — Sterilizer, Ethylene-oxide Gas
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6860

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