FDA 510(k) Application Details - K020214

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

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510(K) Number K020214
Device Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Applicant ENGINEERING CONSULTING SERVICES, INC.
3150 E. 200TH ST.
PRIOR LAKE, MN 55372 US
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Contact AL LIPPINCOTT
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Regulation Number 888.3560

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Classification Product Code JWH
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Date Received 01/22/2002
Decision Date 02/26/2002
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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