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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 K082911
Device Name SMOOTHCOOL HR SYSTEM
Applicant
Jeisys Medical, Inc.
5401 S Cottonwood Ct.
Greenwood Village,  CO  80121
Applicant Contact Kevin Walls
Correspondent
Jeisys Medical, Inc.
5401 S Cottonwood Ct.
Greenwood Village,  CO  80121
Correspondent Contact Kevin Walls
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/30/2008
Decision Date 12/19/2008
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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