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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
Applicant Contact MICHELLE L MCKINLEY
Correspondent
BIOMET, INC.
AIRPORT INDUSTRIAL PARK,
P.O.BOX 587
WARSAW,  IN  46581 -0587
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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