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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Vestibular Analysis
510(k) Number K081602
Device Name DIZZYFIX
Applicant
Clearwater Clinical Limited
100-111 5th Ave. SW
Suite 258
Calgary, Alberta,  CA T2P 3Y6
Applicant Contact MATTHEW BROMWICH
Correspondent
Clearwater Clinical Limited
100-111 5th Ave. SW
Suite 258
Calgary, Alberta,  CA T2P 3Y6
Correspondent Contact MATTHEW BROMWICH
Classification Product Code
LXV  
Date Received06/06/2008
Decision Date 09/19/2008
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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