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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(k) Number K023357
Device Name ARCPM 1050 RESIN-HIPS
Applicant
Biomet Orthopedics, Inc.
56 Eas Bell Dr.
P.O. Box 587
Warsaw,  IN  46582
Applicant Contact TRACY J BICKEL
Correspondent
Biomet Orthopedics, Inc.
56 Eas Bell Dr.
P.O. Box 587
Warsaw,  IN  46582
Correspondent Contact TRACY J BICKEL
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   LZO  
Date Received10/07/2002
Decision Date 11/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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