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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 K964008
Device Name FOUNDATION KNEE SYSTEM
Applicant
Encore Orthopedics, Inc.
8900 Shoal Creek Blvd.,
Bldg. 300
Austin,  TX  78757
Applicant Contact ASHLEY M BOCK
Correspondent
Encore Orthopedics, Inc.
8900 Shoal Creek Blvd.,
Bldg. 300
Austin,  TX  78757
Correspondent Contact ASHLEY M BOCK
Regulation Number888.3560
Classification Product Code
JWH  
Date Received10/07/1996
Decision Date 12/27/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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