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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Ablation, Ultrasound And Accessories
510(k) Number K042096
Device Name MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM
Applicant
Misonix, Inc.
1938 New Hwy.
Farmingdale,  NY  11735
Applicant Contact RONALD R MANNA
Correspondent
Misonix, Inc.
1938 New Hwy.
Farmingdale,  NY  11735
Correspondent Contact RONALD R MANNA
Regulation Number878.4400
Classification Product Code
NTB  
Date Received08/04/2004
Decision Date 01/26/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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