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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, cortical
510(k) Number K102802
Device Name INTEGRA ELECTRODE TUNNELING NEEDLE
Applicant
INTEGRA LIFESCIENCES CORPORATION
311 enterprise dr.
plainsboro,  NJ  08536
Applicant Contact derek cao
Correspondent
INTEGRA LIFESCIENCES CORPORATION
311 enterprise dr.
plainsboro,  NJ  08536
Correspodent Contact derek cao
Regulation Number882.1310
Classification Product Code
GYC  
Date Received09/27/2010
Decision Date 11/23/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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