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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
510(k) Number K082040
Device Name MINISILK FT
Applicant
El.En Electronic Engineering Spa
17 Via Baldanzese
Calenzano,  IT 50041
Applicant Contact ANDREA TOZZI
Correspondent
El.En Electronic Engineering Spa
17 Via Baldanzese
Calenzano,  IT 50041
Correspondent Contact ANDREA TOZZI
Regulation Number878.4810
Classification Product Code
ONF  
Date Received07/18/2008
Decision Date 08/27/2009
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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