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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 K080547
Device Name ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106
Applicant
Aesculap Implant System, Inc.
3 773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact MATTHEW M HULL
Correspondent
Aesculap AG
Am Aesculap Platz
Tuttlingen, Donau
Baden-Wurttemberg,  DK D-78532
Correspondent Contact Kathy Racosky
Regulation Number882.4560
Classification Product Code
HAW  
Date Received02/28/2008
Decision Date 05/23/2008
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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