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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
Original Applicant
HOWMEDICA, INC.
359 veterans blvd.
rutherford,  NJ  07070 -2584
Original 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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