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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 K850840
Device Name HOWMEDICA THREADED ACETABULAR COMPONENT
Original Applicant
PFIZER, INC.
235 e 42nd st.
ny,  NY  10017
Original Contact ronald duchene
Regulation Number888.3330
Classification Product Code
KWA  
Date Received03/01/1985
Decision Date 07/15/1985
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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