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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, SA
4725 CALLE QUETZAL SUITE B
CAMARILLO,  CA  93012
Applicant Contact HEATHER NEELY
Correspondent
MEDACTA INTERNATIONAL, SA
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
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