Cleared Traditional

K990189 - MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER
(FDA 510(k) Clearance)

K990189 · Midmark Corp. · General Hospital

Apr 1999

Decision

89d

Days

Class 2

Risk

K990189 is an FDA 510(k) clearance for the MODIFICATION OF: MIDMARK M-11 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 April 19, 1999, 89 days after receiving the submission on January 20, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6880.

Submission Details

510(k) Number	K990189 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 20, 1999
Decision Date	April 19, 1999
Days to Decision	89 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF