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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 Uncemented Acetabular Component)
510(k) Number K864515
Device Name RING UPM TOTAL HIP REPLACEMENT
Applicant
Downs Surgical , Ltd.
Church Path
Mitcham Surrey,  GB
Applicant Contact GEOFFREY W DOWN
Correspondent
Downs Surgical , Ltd.
Church Path
Mitcham Surrey,  GB
Correspondent Contact GEOFFREY W DOWN
Regulation Number888.3330
Classification Product Code
KWA  
Date Received11/17/1986
Decision Date 03/13/1987
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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