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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 K043223
Device Name DEPUY CAS KNEE INSTRUMENTATION
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DR.
WARSAW,  IN  46581 -0988
Applicant Contact RANDA FRANKLIN
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DR.
WARSAW,  IN  46581 -0988
Correspondent Contact RANDA FRANKLIN
Regulation Number882.4560
Classification Product Code
HAW  
Date Received11/22/2004
Decision Date 03/04/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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