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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 K043374
Device Name DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING
Applicant
Howmedica Osteonics Corp.
325 Corporate Dr.
Malwah,  NJ  07430
Applicant Contact DENISE DUCHENE
Correspondent
Howmedica Osteonics Corp.
325 Corporate Dr.
Malwah,  NJ  07430
Correspondent Contact DENISE DUCHENE
Regulation Number888.3565
Classification Product Code
MBH  
Date Received12/08/2004
Decision Date 02/16/2005
Decision Substantially Equivalent (SESE)
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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