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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 K110306
Device Name SOUND SURGICAL VASER 2.1 LIPO SYSTEM
Applicant
SOUND SURGICAL TECHNOLOGIES LLC.
357 S. MCCASLIN BLVD. #100
LOUISVILLE,  CO  80027
Applicant Contact STEPHEN C SMITH
Correspondent
SOUND SURGICAL TECHNOLOGIES LLC.
357 S. MCCASLIN BLVD. #100
LOUISVILLE,  CO  80027
Correspondent Contact STEPHEN C SMITH
Regulation Number878.5040
Classification Product Code
QPB  
Date Received02/02/2011
Decision Date 06/23/2011
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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