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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 K073300
Device Name MILESMAN PREMIUM
Applicant
Milesman S.L.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact NATALYA VALERIO
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact JAY Y KOGOMA
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/23/2007
Decision Date 12/04/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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