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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 K062248
Device Name AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM
Applicant
North American Clinical Lasers, Ltd.
2755 So. Ames Way
Denver,  CO  80227
Applicant Contact GEOFFREY D SWANK
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact NEIL E DEVINE, JR.
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/03/2006
Decision Date 08/17/2006
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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