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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 K922868
Device Name THOMPSON TYPE HIP PROTHESIS
Original Applicant
OSTEO TECHNOLOGY, INC.
10 west aylesbury rd.
timonium,  MD  21093
Original Contact sam son
Regulation Number888.3330
Classification Product Code
KWA  
Date Received06/04/1992
Decision Date 02/12/1993
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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