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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 K053542
Device Name SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM
Applicant
Praxim S.A
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact RANDY VEALE
Correspondent
Praxim S.A
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact RANDY VEALE
Regulation Number882.4560
Classification Product Code
HAW  
Date Received12/20/2005
Decision Date 04/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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