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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 K100314
Device Name IMNS MEDACTA NAVIGATION SYSTEM,33.221000US
Applicant
Medacta International S.A.
4725 Calle Quetzal Suite B
Camarillo,  CA  93012
Applicant Contact HEATHER NEELY
Correspondent
Medacta International S.A.
4725 Calle Quetzal Suite B
Camarillo,  CA  93012
Correspondent Contact HEATHER NEELY
Regulation Number882.4560
Classification Product Code
HAW  
Date Received02/04/2010
Decision Date 03/31/2010
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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