Cleared Traditional

MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER

K090670 · Midmark Corp. · General Hospital
Jul 2009
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K090670 is an FDA 510(k) clearance for the MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER, a Sterilizer, Steam (Class II — Special Controls, product code FLE), submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on July 7, 2009, 116 days after receiving the submission on March 13, 2009. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6880.

Submission Details

510(k) Number K090670 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2009
Decision Date July 07, 2009
Days to Decision 116 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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