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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 K121590
Device Name VESTIBULAR ANALYSIS APPARATUS
Original Applicant
CAPACITY SPORTS, LLC
2800 pleasant hill
suite 175
pleasant hill,  CA  94523
Original Contact pamela m buckman
Classification Product Code
LXV  
Date Received05/31/2012
Decision Date 09/20/2012
Decision substantially equivalent (SE)
Review Advisory Committee Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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