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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
Original Applicant
NORTH AMERICAN CLINICAL LASERS, LTD.
2755 so. ames way
denver,  CO  80227
Original Contact geoffrey d swank
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/03/2006
Decision Date 08/17/2006
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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