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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ultrasonic Surgical
510(k) Number K971609
Device Name SCULPTURE
Applicant
Servizi Medico Estetici Italinai Srl.
15 Via F. Negri
Casale Monferrato (Al),  IT
Applicant Contact TONIA LATHAM
Correspondent
Servizi Medico Estetici Italinai Srl.
15 Via F. Negri
Casale Monferrato (Al),  IT
Correspondent Contact TONIA LATHAM
Classification Product Code
LFL  
Date Received05/01/1997
Decision Date 08/14/1997
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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