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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 K062471
Device Name ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF
Applicant
Misonix, Inc.
1938 New Highway
Farmingdale,  NY  11735
Applicant Contact RONALD R MANNA
Correspondent
Misonix, Inc.
1938 New Highway
Farmingdale,  NY  11735
Correspondent Contact RONALD R MANNA
Classification Product Code
LFL  
Subsequent Product Code
GEI  
Date Received08/24/2006
Decision Date 10/26/2006
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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