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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 K141580
Device Name STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR
Applicant
Tso3, Inc.
512f NE 81st St., Suite 101
Vancouver,  WA  98665
Applicant Contact THOMAS RICHARDS
Correspondent
Tso3, Inc.
512f NE 81st St., Suite 101
Vancouver,  WA  98665
Correspondent Contact THOMAS RICHARDS
Regulation Number880.2800
Classification Product Code
FRC  
Date Received06/13/2014
Decision Date 12/17/2014
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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