FDA 510(k) Application Details - K960025

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

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510(K) Number K960025
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant INTERMEDICS ORTHOPEDICS
9900 SPECTRUM DR.
AUSTIN, TX 78717 US
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Contact JACQUELYN HUGHES
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Regulation Number 888.3350

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Classification Product Code JDI
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Date Received 01/02/1996
Decision Date 06/07/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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