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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
Original Applicant
DOWNS SURGICAL LTD.
church path
mitcham surrey,  UK
Original Contact geoffrey w down
Regulation Number888.3330
Classification Product Code
KWA  
Date Received11/17/1986
Decision Date 03/13/1987
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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