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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 K081400
Device Name FANNING-PAPPAS MODULAR KNEE BEARING
Applicant
ENDOTEC, INC.
2546 HANSROB RD.
ORLANDO,  FL  32804
Applicant Contact MICHAEL PAPPAS
Correspondent
ENDOTEC, INC.
2546 HANSROB RD.
ORLANDO,  FL  32804
Correspondent Contact MICHAEL PAPPAS
Regulation Number888.3560
Classification Product Code
JWH  
Date Received05/19/2008
Decision Date 02/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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