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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 K250434
Device Name trophon2
Applicant
Nanosonics
7-11 Talavera Rd.
Macquarie Park,  AU 2113
Applicant Contact Nancy Kaiser
Correspondent
Nanosonics
7-11 Talavera Rd.
Macquarie Park,  AU 2113
Correspondent Contact Nancy Kaiser
Regulation Number892.1570
Classification Product Code
OUJ  
Date Received02/14/2025
Decision Date 08/05/2025
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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