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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Suction, Lipoplasty For Removal
510(k) Number K041058
Device Name MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS
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
Regulation Number878.5040
Classification Product Code
QPB  
Date Received04/23/2004
Decision Date 05/17/2004
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
Recalls CDRH Recalls
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