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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 K964178
Device Name PRESS-FIT HIP STEM
Applicant
Encore Orthopedics, Inc.
8900 Shoal Creek Blvd.,
Bldg. 300
Austin,  TX  78757
Applicant Contact ASHLEY M BOCK
Correspondent
Encore Orthopedics, Inc.
8900 Shoal Creek Blvd.,
Bldg. 300
Austin,  TX  78757
Correspondent Contact ASHLEY M BOCK
Regulation Number888.3360
Classification Product Code
LWJ  
Date Received10/18/1996
Decision Date 05/05/1997
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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