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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 K993868
Device Name THE SOUNDVASER DISSECTION SYSTEM
Applicant
Sound Surgical Technologies, LLC
1300 Plz. Ct. N., #203
Lafayette,  CO  80026
Applicant Contact WILLIAM W CIMINO
Correspondent
Sound Surgical Technologies, LLC
1300 Plz. Ct. N., #203
Lafayette,  CO  80026
Correspondent Contact WILLIAM W CIMINO
Classification Product Code
LFL  
Date Received11/15/1999
Decision Date 12/21/1999
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
Recalls CDRH Recalls
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