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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 K050327
Device Name E-POLY (VITAMIN E) ACETABULAR LINERS
Applicant
BIOMET, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW,  IN  46582
Applicant Contact TRACY BICKEL JOHNSON
Correspondent
BIOMET, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW,  IN  46582
Correspondent Contact TRACY BICKEL JOHNSON
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   LWJ   MAY   OQG   OQH  
Date Received02/09/2005
Decision Date 09/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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