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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, Porous Uncemented
510(k) Number K943230
Device Name MAYO HIP PROSTHESIS
Applicant
Mayo Clinic
200 First St. SW
Rocehster,  MN  55902
Applicant Contact B. F MORREY
Correspondent
Mayo Clinic
200 First St. SW
Rocehster,  MN  55902
Correspondent Contact B. F MORREY
Regulation Number888.3358
Classification Product Code
LPH  
Date Received07/06/1994
Decision Date 01/14/1997
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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