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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 K871956
Device Name MODULAR RANGE OF RING PROS. FOR 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 Received05/20/1987
Decision Date 06/23/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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