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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 K070085
Device Name BALANCE REHABILITATION UNIT (BRU)
Applicant
Medicaa (Uruguay) S.A.
1101 S. Capital Texas Hwy.
Suite F254
Austin,  TX  78746
Applicant Contact IAN GORDON
Correspondent
Medicaa (Uruguay) S.A.
1101 S. Capital Texas Hwy.
Suite F254
Austin,  TX  78746
Correspondent Contact IAN GORDON
Classification Product Code
LXV  
Subsequent Product Code
KHX  
Date Received01/09/2007
Decision Date 02/26/2007
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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