FDA 510(k) Application Details - K023302

Device Classification Name Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

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510(K) Number K023302
Device Name Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
Applicant SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS, TN 38116 US
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Contact DAVID HENLEY
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Regulation Number 888.3353

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Classification Product Code MEH
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Date Received 10/03/2002
Decision Date 10/25/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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