FDA 510(k) Application Details - K002735

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

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510(K) Number K002735
Device Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Applicant BIOMET, INC.
P.O. BOX 587
WARSAW, IN 46581-0587 US
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Contact MICHELLE L MCKINLEY
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Regulation Number 888.3560

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Classification Product Code JWH
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Date Received 09/01/2000
Decision Date 09/19/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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