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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 K062146
Device Name UNI KNEE SURGETICS NAVIGATION SYSTEM
Applicant
Praxim S.A
Le Grand Sablon
4 Ave. De L'Obiou
La Tronche,  FR 38700
Applicant Contact MADY BATAILH
Correspondent
Praxim S.A
Le Grand Sablon
4 Ave. De L'Obiou
La Tronche,  FR 38700
Correspondent Contact MADY BATAILH
Regulation Number882.4560
Classification Product Code
HAW  
Date Received07/27/2006
Decision Date 08/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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