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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K131214
Device Name CRANIAL MAP NEURO
Applicant
Stryker Corporate
Boetzinger St. 41
Freiburg, Baden-Wuerttemberg,  DE 79111
Applicant Contact LILIAN ECKERT
Correspondent
Stryker Corporate
Boetzinger St. 41
Freiburg, Baden-Wuerttemberg,  DE 79111
Correspondent Contact LILIAN ECKERT
Regulation Number882.4560
Classification Product Code
HAW  
Date Received04/29/2013
Decision Date 10/18/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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