Cleared Traditional

MIDMARK M4*9 EASYCLAVE STEAM STERILIZER

K992744 · Midmark Corp. · General Hospital
Jan 2000
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K992744 is an FDA 510(k) clearance for the MIDMARK M4*9 EASYCLAVE 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 January 10, 2000, 147 days after receiving the submission on August 16, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6880.

Submission Details

510(k) Number K992744 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 1999
Decision Date January 10, 2000
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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