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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
Applicant
BIOMET, INC.
airport industrial park,
p.o.box 587
warsaw,  IN  46581 0587
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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