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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 SA
LE GRAND SABLON
4 AVENUE DE L'OBIOU
LA TRONCHE,  FR 38700
Applicant Contact JIHANE ZEMMOURI
Correspondent
PRAXIM SA
LE GRAND SABLON
4 AVENUE 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
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