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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 K072262
Device Name GENTLERAY 980 DIODE LASER SYSTEM
Applicant
Kavo America
340 E. Main St.
Lake Zurich,  IL  60047
Applicant Contact JOHN MILLER
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/15/2007
Decision Date 10/26/2007
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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