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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, limb brace
510(k) Number K143458
Device Name Neurosplint
Applicant
Neurospectrum LLC
3 Crown Crt
Rancho Mirage,  CA  92270
Applicant Contact David Kernan
Correspondent
Nu Device Consulting LLC
27 Redstone Rd
Newport,  NH  03773
Correspondent Contact Jean Bigoney
Regulation Number890.3475
Classification Product Code
IQI  
Subsequent Product Code
ILH  
Date Received12/04/2014
Decision Date 08/13/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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