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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
Recalls CDRH Recalls
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