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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/ceramic/polymer, cemented or non-porous, uncemented
510(k) Number K933942
Device Name SOLUTION BOWED FEMORAL HIP PROTSTHESIS
Original Applicant
DEPUY, INC.
p.o. box 988
700 orthopaedic drive
warsaw,  IN  46581 -0988
Original Contact sally foust
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
LPH  
Date Received08/12/1993
Decision Date 10/14/1994
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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