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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 K992472
Device Name SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM
Applicant
Clinicon Corp.
5825 Avenida Encinas, #101
Carlsbad,  CA  92008
Applicant Contact GERALD S PALECKI
Correspondent
Clinicon Corp.
5825 Avenida Encinas, #101
Carlsbad,  CA  92008
Correspondent Contact GERALD S PALECKI
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/26/1999
Decision Date 09/08/1999
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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