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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
510(k) Number K032108
Device Name SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)
Applicant
AESCULAP, INC.
3773 Corporate Parkway
Center Valley,  PA  18034
Applicant Contact JOYCE KILROY
Correspondent
AESCULAP, INC.
3773 Corporate Parkway
Center Valley,  PA  18034
Correspondent Contact JOYCE KILROY
Regulation Number888.3565
Classification Product Code
MBH  
Date Received07/08/2003
Decision Date 01/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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