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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 K052851
Device Name VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS)
Applicant
Mako Surgical Corp.
2901 Simms St.
Hollywood,  FL  33020
Applicant Contact WILLIAM F TAPIA
Correspondent
Mako Surgical Corp.
2901 Simms St.
Hollywood,  FL  33020
Correspondent Contact WILLIAM F TAPIA
Regulation Number882.4560
Classification Product Code
HAW  
Date Received10/11/2005
Decision Date 11/18/2005
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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