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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 K000927
Device Name ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4
Applicant
MISONIX, INC.
1938 NEW HIGHWAY
FARMINGDALE,  NY  11735
Applicant Contact ALBERT F CLANCY JR.
Correspondent
MISONIX, INC.
1938 NEW HIGHWAY
FARMINGDALE,  NY  11735
Correspondent Contact ALBERT F CLANCY JR.
Classification Product Code
LFL  
Date Received03/22/2000
Decision Date 10/10/2000
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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