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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 uncemented acetabular component)
510(k) Number K993438
Device Name METAL ON METAL ACETABULAR SYSTEM
Original Applicant
BIOMET, INC.
airport industrial park,
p.o.box 587
warsaw,  IN  46581 -0587
Original Contact michelle l mckinley
Regulation Number888.3330
Classification Product Code
KWA  
Date Received10/12/1999
Decision Date 05/18/2000
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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