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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Biological Sterilization Process
510(k) Number K112018
Device Name SMART READ EZTEST STEAM
Applicant
Mesa Laboratories, Inc.
10 Evergreen Dr.
Bozeman,  MT  59715
Applicant Contact WENDY ROYALTY
Correspondent
Mesa Laboratories, Inc.
10 Evergreen Dr.
Bozeman,  MT  59715
Correspondent Contact WENDY ROYALTY
Regulation Number880.2800
Classification Product Code
FRC  
Date Received07/14/2011
Decision Date 01/30/2012
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
Predetermined Change
Control Plan Authorized		 No
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