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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
510(k) Number K173865
Device Name trophon2
Applicant
Nanosonics Limited
14 Mars Rd.
Lane Cove,  AU 2066
Applicant Contact Ruth Cremin
Correspondent
Nanosonics Limited
14 Mars Rd.
Lane Cove,  AU 2066
Correspondent Contact Ruth Cremin
Regulation Number892.1570
Classification Product Code
OUJ  
Date Received12/20/2017
Decision Date 04/24/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
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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