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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 K112267
Device Name NEUROLAC(R) NERVE GUIDE
Applicant
Polyganics B.V.,
Rozenburglaan 15a
Groningen,  NL 9727-DL
Applicant Contact BETTY IJMKER
Correspondent
Polyganics B.V.,
Rozenburglaan 15a
Groningen,  NL 9727-DL
Correspondent Contact BETTY IJMKER
Regulation Number882.5275
Classification Product Code
JXI  
Date Received08/08/2011
Decision Date 10/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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