FDA 510(k) Application Details - K021740

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

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510(K) Number K021740
Device Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Applicant DJ ORTHOPEDICS, LLC
2985 SCOTT ST.
VISTA, CA 92083 US
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Contact NORA C.R. YORK
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Regulation Number 888.3560

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Classification Product Code JWH
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Date Received 05/28/2002
Decision Date 09/23/2002
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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