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510(k) K060819

COOL.CLICK 2 by Medical House Products Limited — Product Code KZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2006
Date Received
March 27, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Fluid, Non-Electrically Powered
Device Class
Class II
Regulation Number
880.5430
Review Panel
HO
Submission Type

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