Cleared Traditional

STERI-VAC GAS STERILIZER MODEL 8XL

K941748 · 3M Health Care, Ltd. · General Hospital
Dec 1994
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K941748 is an FDA 510(k) clearance for the STERI-VAC GAS STERILIZER MODEL 8XL, a Sterilizer, Ethylene-oxide Gas (Class II — Special Controls, product code FLF), submitted by 3M Health Care, Ltd. (St. Paul, US). The FDA issued a Cleared decision on December 2, 1994, 238 days after receiving the submission on April 8, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6860.

Submission Details

510(k) Number K941748 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 1994
Decision Date December 02, 1994
Days to Decision 238 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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