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510(k) K070085

BALANCE REHABILITATION UNIT (BRU) by Medicaa (Uruguay) S.A. — Product Code LXV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2007
Date Received
January 9, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Vestibular Analysis
Device Class
Class U
Regulation Number
Review Panel
EN
Submission Type

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