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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 K032396
Device Name RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS
Applicant
BIOMET, INC.
56 EAST BELL DR.
WARSAW,  IN  46581 -0587
Applicant Contact GARY BAKER
Correspondent
BIOMET, INC.
56 EAST BELL DR.
WARSAW,  IN  46581 -0587
Correspondent Contact GARY BAKER
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
LPH  
Date Received08/04/2003
Decision Date 08/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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