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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 K121580
Device Name SURELASE CO2 LASER SYSTEM
Applicant
Clinicon Corp.
1107 259th St. NW
Stanwood,  WA  98292 -4834
Applicant Contact GERALD PALECKI
Correspondent
Clinicon Corp.
1107 259th St. NW
Stanwood,  WA  98292 -4834
Correspondent Contact GERALD PALECKI
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/30/2012
Decision Date 09/25/2012
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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