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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 K031693
Device Name MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA
Applicant
BIOMET, INC.
56 BELL DR.
PO BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact PATRICIA S BERES
Correspondent
BIOMET, INC.
56 BELL DR.
PO BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact PATRICIA S BERES
Regulation Number888.3358
Classification Product Code
LPH  
Date Received06/02/2003
Decision Date 08/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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