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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, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K070981
Device Name SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (PLASMAPORE)
Applicant
AESCULAP IMPLANT SYSTEMS, INC.
3773 CORPORATE PKWY.
CENTER VALLEY,  PA  18034
Applicant Contact Lisa Boyle
Correspondent
AESCULAP IMPLANT SYSTEMS, INC.
3773 CORPORATE PKWY.
CENTER VALLEY,  PA  18034
Correspondent Contact Lisa Boyle
Regulation Number888.3560
Classification Product Code
JWH  
Date Received04/06/2007
Decision Date 08/21/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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