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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 K973982
Device Name ORBITAL RECONSTRUCTION PLATES
Applicant
HOWMEDICA, INC.
359 VETERANS BLVD.
RUTHERFORD,  NJ  07070 -2584
Applicant Contact VIVIAN KELLY
Correspondent
HOWMEDICA, INC.
359 VETERANS BLVD.
RUTHERFORD,  NJ  07070 -2584
Correspondent Contact VIVIAN KELLY
Regulation Number888.3030
Classification Product Code
HRS  
Date Received10/20/1997
Decision Date 01/12/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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