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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nail, fixation, bone
510(k) Number K032634
Device Name NORMED COMPRESSION BONE SCREW SYSTEM
Applicant
NOVIACE CORPORATION
809 CARTER LANE
PARAMUS,  NJ  07652
Applicant Contact ALBERT ENAYATI
Correspondent
NOVIACE CORPORATION
809 CARTER LANE
PARAMUS,  NJ  07652
Correspondent Contact ALBERT ENAYATI
Regulation Number888.3030
Classification Product Code
JDS  
Date Received08/26/2003
Decision Date 10/06/2003
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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