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510(k) K081602

DIZZYFIX by Clearwater Clinical Limited — Product Code LXV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2008
Date Received
June 6, 2008
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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