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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 K060282
Device Name TOTAL KNEE SURGETICS NAVIGATION SYSTEM
Applicant
PRAXIM SA
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Applicant Contact RANDY VEALE
Correspondent
PRAXIM SA
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Correspondent Contact RANDY VEALE
Regulation Number882.4560
Classification Product Code
HAW  
Date Received02/03/2006
Decision Date 04/10/2006
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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