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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/ceramic/polymer, cemented or non-porous, uncemented
510(k) Number K030373
Device Name ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM
Applicant
CENTERPULSE ORTHOPEDICS, INC.
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Applicant Contact AUDREY SWEARINGEN
Correspondent
CENTERPULSE ORTHOPEDICS, INC.
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Correspondent Contact AUDREY SWEARINGEN
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   KWL   KWY  
Date Received02/04/2003
Decision Date 03/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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