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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 K033668
Device Name NAVIPRO KNEE SOFTWARE MODULE
Applicant
Kinamed, Inc.
820 Flynn Rd.
Camarillo,  CA  93012
Applicant Contact VINEET K SARIN
Correspondent
Kinamed, Inc.
820 Flynn Rd.
Camarillo,  CA  93012
Correspondent Contact VINEET K SARIN
Regulation Number882.4560
Classification Product Code
HAW  
Date Received11/21/2003
Decision Date 03/11/2004
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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