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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 K072267
Device Name TOTAL HIP SURGETICS NAVIGATION SYSTEM
Applicant
Praxim S.A
Le Grand Sablon
4 Ave. De L'Obiou
La Tronche,  FR 38700
Applicant Contact JIHANE ZEMMOURI
Correspondent
Praxim S.A
Le Grand Sablon
4 Ave. De L'Obiou
La Tronche,  FR 38700
Correspondent Contact JIHANE ZEMMOURI
Regulation Number882.4560
Classification Product Code
HAW  
Date Received08/15/2007
Decision Date 12/10/2007
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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