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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, cemented
510(k) Number K022094
Device Name PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING
Applicant
BIOMET, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact TRACY J BICKEL
Correspondent
BIOMET, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact TRACY J BICKEL
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
LPH  
Date Received06/27/2002
Decision Date 07/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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