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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 K010637
Device Name SONOTOME ULTRASONIC ASPIRATOR TIPS
Applicant
Synergetics, Inc.
88 Hubble Dr.
St. Charles,  MO  63304 -8694
Applicant Contact ALAN T BECKMAN
Correspondent
Synergetics, Inc.
88 Hubble Dr.
St. Charles,  MO  63304 -8694
Correspondent Contact ALAN T BECKMAN
Classification Product Code
LFL  
Date Received03/05/2001
Decision Date 04/20/2001
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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