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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 K941306
Device Name FOUNDATION KNEE AUGMENTATION BLOCKS
Original Applicant
ENCORE ORTHOPEDICS, INC.
8920 business park dr.
sutie 380
austin,  TX  78759
Original Contact j.d. webb
Regulation Number888.3560
Classification Product Code
JWH  
Date Received03/17/1994
Decision Date 02/08/1995
Decision (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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