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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 (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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