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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Two Or More Sterilant Sterilizer
510(k) Number K153689
Device Name STERIZONE Sterilizer
Applicant
Tso3, Inc.
2505 Ave. Dalton
Quebec,  CA G1P 3S5
Applicant Contact NATHALIE RACETTE
Correspondent
Im3, Inc.
7720 NE Hwy. 99
Suite D #110
Vancouver,  WA  98665
Correspondent Contact THOMAS RICHARDS
Regulation Number880.6860
Classification Product Code
PJJ  
Date Received12/23/2015
Decision Date 06/30/2016
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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