FDA 510(k) Application Details - K021313

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

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510(K) Number K021313
Device Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Applicant AESCULAP, INC.
3773 Corporate Parkway
Center Valley, PA 18034 US
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Contact JOYCE KILROY
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Regulation Number 888.3560

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Classification Product Code JWH
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Date Received 04/25/2002
Decision Date 07/22/2002
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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