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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 Cemented Acetabular Component)
510(k) Number K950542
Device Name METAL BACKED ACETABULAR COMPONENT
Applicant
ENCORE ORTHOPEDICS, INC.
8920 BUSINESS PARK DR.
SUTIE 380
AUSTIN,  TX  78759
Applicant Contact J. D WEBB
Correspondent
ENCORE ORTHOPEDICS, INC.
8920 BUSINESS PARK DR.
SUTIE 380
AUSTIN,  TX  78759
Correspondent Contact J. D WEBB
Regulation Number888.3320
Classification Product Code
JDL  
Date Received02/07/1995
Decision Date 05/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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