FDA 510(k) Application Details - K021466

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

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510(K) Number K021466
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant HAYES MEDICAL, INC.
1115 WINDFIELD WAY, SUITE 100
EL DORADO HILLS, CA 95762-9623 US
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Contact WILLIAM J GRIFFIN
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Regulation Number 888.3358

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Classification Product Code LPH
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Date Received 05/07/2002
Decision Date 07/24/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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