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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 K861566
Device Name SLR BIPOLAR HIP ENDOPROSTHESIS
Applicant
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Applicant Contact SPIRES, JR
Correspondent
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Correspondent Contact SPIRES, JR
Regulation Number888.3390
Classification Product Code
KWY  
Date Received04/25/1986
Decision Date 05/12/1986
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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