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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ultrasonic Surgical
510(k) Number K212060
Device Name neXus Ultrasonic Surgical Aspirator System
Applicant
Misonix, Inc.
1938 New Highway
Farmingdale,  NY  11735
Applicant Contact John Salerno
Correspondent
Misonix, Inc.
1938 New Highway
Farmingdale,  NY  11735
Correspondent Contact John Salerno
Classification Product Code
LFL  
Subsequent Product Code
GEI  
Date Received07/01/2021
Decision Date 12/13/2021
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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