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510(k) K070676

KOREBALANCE (KINESTHETIC ABILITY TRAINER) by Sportkat, LLC — Product Code LXV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2007
Date Received
March 12, 2007
Clearance Type
Special
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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