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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 K012702
Device Name BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1
Applicant
ENDOTEC, INC.
20 VALLEY ST.
SOUTH ORANGE,  NJ  07079
Applicant Contact ALEX CANONACO
Correspondent
ENDOTEC, INC.
20 VALLEY ST.
SOUTH ORANGE,  NJ  07079
Correspondent Contact ALEX CANONACO
Regulation Number888.3560
Classification Product Code
JWH  
Date Received08/14/2001
Decision Date 01/30/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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