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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, Femoral, Resurfacing
510(k) Number K950998
Device Name MODUILAR UNIPOLAR
Applicant
Intermedics Orthopedics
1300-C E. Anderson Ln.
Austin,  TX  78752
Applicant Contact JOANN RINGER-KUHNE
Correspondent
Intermedics Orthopedics
1300-C E. Anderson Ln.
Austin,  TX  78752
Correspondent Contact JOANN RINGER-KUHNE
Regulation Number888.3400
Classification Product Code
KXA  
Date Received03/03/1995
Decision Date 04/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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