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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 K150301
Device Name NavSuite3 Kit
Applicant
Stryker Leibinger GmbH & Co. KG - Navigation
Boetzinger Strasse 41
Freiburg,  DE D-79111
Applicant Contact Robin L Rowe
Correspondent
Stryker Leibinger GmbH & Co. KG - Navigation
Boetzinger Strasse 41
Freiburg,  DE D-79111
Correspondent Contact Robin L Rowe
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Code
OLO  
Date Received02/06/2015
Decision Date 07/08/2015
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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