FDA 510(k) Application Details - K926257

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

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510(K) Number K926257
Device Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Applicant DOW CORNING WRIGHT
P.O. BOX 100
ARLINGTON, TN US
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Contact ALICIA FARAGE
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Regulation Number 888.3560

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Classification Product Code JWH
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Date Received 12/18/1992
Decision Date 05/18/1993
Decision SE - Substantially Equivalent
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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