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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 K050262
Device Name U2 ACETABULAR COMPONENT
Applicant
United Orthopedic Corp.
# 57, Park Ave. 2, Science Park
Hsinchu,  TW 300
Applicant Contact GENE HUANG
Correspondent
United Orthopedic Corp.
# 57, Park Ave. 2, Science Park
Hsinchu,  TW 300
Correspondent Contact GENE HUANG
Regulation Number888.3360
Classification Product Code
LWJ  
Subsequent Product Code
MEH  
Date Received02/04/2005
Decision Date 08/15/2005
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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