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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 K110255
Device Name SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM
Applicant
Sound Surgical Technologies, LLC
357 S. Mccaslin Blvd. #100
Louisville,  CO  80027
Applicant Contact STEPHEN C SMITH
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number878.5040
Classification Product Code
QPB  
Date Received01/28/2011
Decision Date 04/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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