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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, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(k) Number K032418
Device Name DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
Applicant
HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
ALLENDALE,  NJ  07401 -1677
Applicant Contact DENISE DUCHENE
Correspondent
HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
ALLENDALE,  NJ  07401 -1677
Correspondent Contact DENISE DUCHENE
Regulation Number888.3565
Classification Product Code
MBH  
Date Received08/05/2003
Decision Date 09/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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