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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 K063698
Device Name CO2 LASER SYSTEM, MODEL C-LAS
Applicant
CLINICON CORP.
16787 BERNARDO CENTER DR.
SUITE A
SAN DIEGO,  CA  92128
Applicant Contact KIM BLOOM
Correspondent
CLINICON CORP.
16787 BERNARDO CENTER DR.
SUITE A
SAN DIEGO,  CA  92128
Correspondent Contact KIM BLOOM
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/13/2006
Decision Date 03/02/2007
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
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