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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/Polymer, Uncemented
510(k) Number K952297
Device Name FOUNDATION TEXTURED STEM
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 Number888.3360
Classification Product Code
LWJ  
Date Received05/16/1995
Decision Date 07/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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