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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Cleaner, Ultrasound
510(k) Number K123980
Device Name SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES
Applicant
Misonix, Inc.
1938 New Highway
Farmingdale,  NY  11735
Applicant Contact RONALD MANNA
Correspondent
Misonix, Inc.
1938 New Highway
Farmingdale,  NY  11735
Correspondent Contact RONALD MANNA
Regulation Number878.4410
Classification Product Code
NRB  
Subsequent Product Code
FQH  
Date Received12/26/2012
Decision Date 03/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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