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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 K060121
Device Name BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS
Applicant
Biomet Manufacturing Corp
56 E. Bell Dr. P.O. Box 587
Warsaw,  IN  46581 -0587
Applicant Contact LESTER F PADILLA
Correspondent
Biomet Manufacturing Corp
56 E. Bell Dr. P.O. Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact LESTER F PADILLA
Regulation Number882.4560
Classification Product Code
HAW  
Date Received01/17/2006
Decision Date 03/21/2006
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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