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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
Original Applicant
KOROS USA, INC.
610 flinn ave.
moorpark,  CA  93021
Original 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
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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