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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Fluid, Non-Electrically Powered
510(k) Number K060819
Device Name COOL.CLICK 2
Applicant
Medical House Products Limited
199, Newhall Rd.
Sheffield,  GB S9 2QJ
Applicant Contact ROSE Y GUANG
Correspondent
Medical House Products Limited
199, Newhall Rd.
Sheffield,  GB S9 2QJ
Correspondent Contact ROSE Y GUANG
Regulation Number880.5430
Classification Product Code
KZE  
Date Received03/27/2006
Decision Date 06/16/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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