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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 K983509
Device Name INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT
Applicant
Sulzer Orthopedics, Inc.
9900 Spectrum Dr.
Austin,  TX  78717
Applicant Contact SHAVAWN E PARDUHN
Correspondent
Sulzer Orthopedics, Inc.
9900 Spectrum Dr.
Austin,  TX  78717
Correspondent Contact SHAVAWN E PARDUHN
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
JDI  
Date Received10/07/1998
Decision Date 02/03/1999
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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