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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
510(k) Number K120328
Device Name ORIGINS LIPOHARVESTING SYSTEM
Applicant
SOUND SURGICAL TECHNOLOGIES LLC.
357 McCaslin Blvd Ste 100
LOUISVILLE,  CO  80027
Applicant Contact STEPHEN C SMITH
Correspondent
SOUND SURGICAL TECHNOLOGIES LLC.
357 McCaslin Blvd Ste 100
LOUISVILLE,  CO  80027
Correspondent Contact STEPHEN C SMITH
Regulation Number878.5040
Classification Product Code
MUU  
Date Received02/02/2012
Decision Date 09/17/2012
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
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