FDA 510(k) Application Details - K030205

Device Classification Name Prosthesis, Hip, Hemi-, Femoral, Metal

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510(K) Number K030205
Device Name Prosthesis, Hip, Hemi-, Femoral, Metal
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 888.3360

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Classification Product Code KWL
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Date Received 01/21/2003
Decision Date 04/01/2003
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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