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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 K031337
Device Name ACUMEN SURGICAL NAVIGATION SYSTEM
Applicant
Biomet, Inc.
56 E. Bell Dr. P.O. Box 587
Warsaw,  IN  46581 -0587
Applicant Contact KRISTINE C ARNOLD
Correspondent
Biomet, Inc.
56 E. Bell Dr. P.O. Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact KRISTINE C ARNOLD
Regulation Number882.4560
Classification Product Code
HAW  
Date Received04/28/2003
Decision Date 09/15/2003
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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