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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K151855
Device Name SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber
Applicant
Surgical Laser Incorporated
Suite 337 7950 NW 53rd St.
Miami,  FL  33166
Applicant Contact GORDON WILLOX
Correspondent
F. Kettenbaum , Ltd.
Tal-Bonzu - Triq L - Imghazel
Swieqi,  MT SWQ 3141
Correspondent Contact F. KETTENBAUM
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/08/2015
Decision Date 04/15/2016
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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