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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 K990572
Device Name SONOTOME
Applicant
Sonokinetics, Inc.
7 Tiffany Trl.
Hopkinton,  MA 
Applicant Contact DEBBIE IAMPIETRO
Correspondent
Sonokinetics, Inc.
7 Tiffany Trl.
Hopkinton,  MA 
Correspondent Contact DEBBIE IAMPIETRO
Classification Product Code
LFL  
Date Received02/23/1999
Decision Date 05/21/1999
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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