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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Elbow, Hemi-, Radial, Polymer
510(k) Number K001385
Device Name HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS
Applicant
Howmedica Osteonics Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070
Applicant Contact JENNIFER A DAUDELIN
Correspondent
Howmedica Osteonics Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070
Correspondent Contact JENNIFER A DAUDELIN
Regulation Number888.3170
Classification Product Code
KWI  
Date Received05/02/2000
Decision Date 07/27/2000
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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