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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K974289
Device Name EPI-UNION PLATING SYSTEM
Applicant
Howmedica, Inc.
359 Veterans Blvd.
Rutherford,  NJ  07070
Applicant Contact VIVIAN KELLY
Correspondent
Howmedica, Inc.
359 Veterans Blvd.
Rutherford,  NJ  07070
Correspondent Contact VIVIAN KELLY
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received11/14/1997
Decision Date 02/12/1998
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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