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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 K940861
Device Name PCA(R) MODULAR TOTAL KNEE TIB INSERT DUROCON BASEPLATE
Applicant
HOWMEDICA CORP.
359 VETERANS BLVD.
RUTHERFORD,  NJ  07070
Applicant Contact ROBERT E SMITH
Correspondent
HOWMEDICA CORP.
359 VETERANS BLVD.
RUTHERFORD,  NJ  07070
Correspondent Contact ROBERT E SMITH
Regulation Number888.3560
Classification Product Code
JWH  
Date Received02/23/1994
Decision Date 09/18/1995
Decision Substantially Equivalent (SESE)
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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