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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name neurosurgical nerve locator
510(K) Number K120590
Models 7332-85, 7332-86, 7332-87
Device Name DILATOR TUBE SET
Applicant
KOROS USA, INC.
610 flinn ave.
moorpark,  CA  93021
Contact gabriel koros
Regulation Number874.1820
Classification Product Code
PDQ  
Subsequent Product Code
GXZ  
Date Received02/28/2012
Decision Date 05/07/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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