FDA 510(k) Application Details - K021803

Device Classification Name Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

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510(K) Number K021803
Device Name Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Applicant SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS, TN 38116 US
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Contact JANET JOHNSON GREEN
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Regulation Number 888.3310

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Classification Product Code KWZ
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Date Received 06/03/2002
Decision Date 12/19/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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