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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 K103059
Device Name TROPHON
Applicant
Nanosonics Limited
24/566 Gardeners Rd.
Alexandria, Nsw,  AU 2015
Applicant Contact RON WEINBERGER
Correspondent
Nanosonics Limited
24/566 Gardeners Rd.
Alexandria, Nsw,  AU 2015
Correspondent Contact RON WEINBERGER
Regulation Number892.1570
Classification Product Code
OUJ  
Date Received10/15/2010
Decision Date 02/24/2011
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
Recalls CDRH Recalls
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