FDA 510(k) Application Details - K030151

Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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510(K) Number K030151
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-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 888.3353

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Classification Product Code LZO
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Date Received 01/15/2003
Decision Date 04/10/2003
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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