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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cuff, nerve
510(k) Number K162741
Device Name AxoGuard Nerve Connector
Applicant
COOK BIOTECH INCORPORATED
1425 INNOVATION PLACE
WEST LAFAYETTE,  IN  47906
Applicant Contact PERRY W. GUINN
Correspondent
COOK BIOTECH INCORPORATED
1425 INNOVATION PLACE
WEST LAFAYETTE,  IN  47906
Correspondent Contact KATRINA L. MOLLAND
Regulation Number882.5275
Classification Product Code
JXI  
Date Received09/30/2016
Decision Date 10/31/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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