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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 K183661
Device Name ClearEdge Balance System
Applicant
Quadrant Biosciences
505 Irving Avenue
Syracuse,  NY  13210
Applicant Contact Bryan Greene
Correspondent
Quadrant Biosciences
505 Irving Avenue
Syracuse,  NY  13210
Correspondent Contact Bryan Greene
Classification Product Code
LXV  
Date Received12/27/2018
Decision Date 10/22/2019
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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