Cleared Traditional

MIDMARK M9 ULTRACLAVE STEAM STERILIZER

K023348 · Midmark Corp. · General Hospital
Mar 2003
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K023348 is an FDA 510(k) clearance for the MIDMARK M9 ULTRACLAVE STEAM STERILIZER, a Sterilizer, Steam (Class II — Special Controls, product code FLE), submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on March 3, 2003, 147 days after receiving the submission on October 7, 2002. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6880.

Submission Details

510(k) Number K023348 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 2002
Decision Date March 03, 2003
Days to Decision 147 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FLE — Sterilizer, Steam
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6880

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