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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 K022051
Device Name SOUNDVASER SYSTEM
Applicant
SOUND SURGICAL TECHNOLOGIES LLC.
1300 PLAZA CT. NORTH, #103
LAFAYETTE,  CO  80026
Applicant Contact WILLIAM W CIMINO
Correspondent
SOUND SURGICAL TECHNOLOGIES LLC.
1300 PLAZA CT. NORTH, #103
LAFAYETTE,  CO  80026
Correspondent Contact WILLIAM W CIMINO
Regulation Number878.5040
Classification Product Code
QPB  
Date Received06/24/2002
Decision Date 09/11/2002
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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