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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 K141163
FOIA Releasable 510(k) K141163
Device Name STERIZONE STERILIZER
Applicant
TSO3 INC.
512F NE 81ST STREET, SUITE 110
VANCOUVER,  WA  98665
Applicant Contact THOMAS RICHARDS, PH.D.
Correspondent
TSO3 INC.
512F NE 81ST STREET, SUITE 110
VANCOUVER,  WA  98665
Correspondent Contact THOMAS RICHARDS, PH.D.
Regulation Number880.6860
Classification Product Code
PJJ  
Date Received05/05/2014
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
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