Cleared Traditional

MODEL #M9 ULTRACLAVE STEAM STERILIZER

K911322 · Midmark Corp. · General Hospital
Aug 1991
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K911322 is an FDA 510(k) clearance for the MODEL #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 August 26, 1991, 153 days after receiving the submission on March 26, 1991. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6880.

Submission Details

510(k) Number K911322 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 1991
Decision Date August 26, 1991
Days to Decision 153 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

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

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