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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
Original Applicant
CLINICON CORP.
1107 259th st nw
stanwood,  WA  98292 4834
Original Contact gerald palecki
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/30/2012
Decision Date 09/25/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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