FDA 510(k) Application Details - K962007

Device Classification Name Prosthesis, Hip, Acetabular Mesh

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510(K) Number K962007
Device Name Prosthesis, Hip, Acetabular Mesh
Applicant DEPUY, INC.
2747 ARMSTRONG LN.
DAYTON, OH 45414 US
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Contact CHERYL HASTINGS
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Regulation Number 878.3300

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Classification Product Code JDJ
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Date Received 05/22/1996
Decision Date 08/01/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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