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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 K010311
Device Name LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE
Applicant
Euromi S.A
P.O. Box 2156
Huntington,  CT  06484
Applicant Contact JOSEPH M AZARY
Correspondent
Euromi S.A
P.O. Box 2156
Huntington,  CT  06484
Correspondent Contact JOSEPH M AZARY
Regulation Number878.5040
Classification Product Code
QPB  
Date Received02/01/2001
Decision Date 06/29/2001
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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