Cleared Special

OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500

K081094 · Olympic Medical Corp. · General Hospital
Jun 2008
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K081094 is an FDA 510(k) clearance for the OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500, a Disinfector, Medical Devices (Class II — Special Controls, product code MEC), submitted by Olympic Medical Corp. (Seattle, US). The FDA issued a Cleared decision on June 20, 2008, 64 days after receiving the submission on April 17, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6992.

Submission Details

510(k) Number K081094 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2008
Decision Date June 20, 2008
Days to Decision 64 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MEC — Disinfector, Medical Devices
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6992