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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, femoral component, cemented, metal
510(k) Number K942028
Device Name RX90 FEMORAL COMPONENT
Original Applicant
BIOMET, INC.
p.o. box 587
warsaw,  IN  46581 -0587
Original Contact patricia s beres
Regulation Number888.3360
Classification Product Code
JDG  
Date Received04/26/1994
Decision Date 09/19/1994
Decision (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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