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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 K122096
Model 40800001
Device Name KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM
Original Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 e. grand ave.
el segundo,  CA  90245
Original Contact leigh spotten
Regulation Number882.4560
Classification Product Code
HAW  
Date Received07/16/2012
Decision Date 09/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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