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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 K132353
Device Name SUCTION LIPOPLASTY ACCESSORIES
Applicant
Inex
Za La Gobette
60540 Puiseux Le Hauberger
Puiseux Le Hauberger,  FR 60540
Applicant Contact RAYMOND PATEL
Correspondent
Inex
Za La Gobette
60540 Puiseux Le Hauberger
Puiseux Le Hauberger,  FR 60540
Correspondent Contact RAYMOND PATEL
Regulation Number878.5040
Classification Product Code
QPB  
Date Received07/29/2013
Decision Date 07/30/2014
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
Predetermined Change
Control Plan Authorized		 No
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