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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, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(k) Number K981238
Device Name BIPOLAR FEMORAL HEAD
Applicant
Whiteside Biomechanics, Inc.
12634 Olive Blvd.
Creve Coeur,  MO  63141
Applicant Contact MICHAEL C WALL
Correspondent
Whiteside Biomechanics, Inc.
12634 Olive Blvd.
Creve Coeur,  MO  63141
Correspondent Contact MICHAEL C WALL
Regulation Number888.3390
Classification Product Code
KWY  
Date Received04/03/1998
Decision Date 08/21/1998
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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