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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement Obturator
510(k) Number K951930
Device Name CEMENTRALIZER DISTAL STEM CENTRALIZER
Applicant
Depuy, Inc.
P.O. Box 988
700 Orthopaedic Dr.
Warsaw,  IN  46581
Applicant Contact CHERYL K HASTINGS
Correspondent
Depuy, Inc.
P.O. Box 988
700 Orthopaedic Dr.
Warsaw,  IN  46581
Correspondent Contact CHERYL K HASTINGS
Regulation Number878.3300
Classification Product Code
LZN  
Date Received04/05/1995
Decision Date 07/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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