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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sterilizer, steam
510(k) Number K023348
Device Name MIDMARK M9 ULTRACLAVE STEAM STERILIZER
Applicant
MIDMARK CORP.
60 VISTA DR.
P.O. BOX 286
VERSAILLES,  OH  45380
Applicant Contact GENE JARSHNARGER
Correspondent
MIDMARK CORP.
60 VISTA DR.
P.O. BOX 286
VERSAILLES,  OH  45380
Correspondent Contact GENE JARSHNARGER
Regulation Number880.6880
Classification Product Code
FLE  
Date Received10/07/2002
Decision Date 03/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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