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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, Cemented
510(k) Number K960025
Device Name PROTEK LOW PROFILE ACETABULAR CUP
Applicant
Intermedics Orthopedics
9900 Spectrum Dr.
Austin,  TX  78717
Applicant Contact JACQUELYN HUGHES
Correspondent
Intermedics Orthopedics
9900 Spectrum Dr.
Austin,  TX  78717
Correspondent Contact JACQUELYN HUGHES
Regulation Number888.3350
Classification Product Code
JDI  
Date Received01/02/1996
Decision Date 06/07/1996
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
Recalls CDRH Recalls
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