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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K141698
Device Name STERIZONE CHEMICAL INDICATOR
Applicant
Tso3, Inc.
512f NE 81st St., Suite 110
Vancouver,  WA  98665
Applicant Contact THOMAS RICHARDS, PH.D.
Correspondent
Tso3, Inc.
512f NE 81st St., Suite 110
Vancouver,  WA  98665
Correspondent Contact THOMAS RICHARDS, PH.D.
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received06/24/2014
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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