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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 K090670
Device Name MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER
Applicant
Midmark Corp.
60 Vista Dr.
P.O. Box 286
Versailles,  OH  45380
Applicant Contact GARY BENNING
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact JAY Y KOGOMA
Regulation Number880.6880
Classification Product Code
FLE  
Date Received03/13/2009
Decision Date 07/07/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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