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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K030989
Device Name OSTEOSORB TACK FIXATION SYSTEM
Applicant
Noviace Corporation
809 Carter Ln.
Paramus,  NJ  07652
Applicant Contact ALBERT ENAYATI
Correspondent
Noviace Corporation
809 Carter Ln.
Paramus,  NJ  07652
Correspondent Contact ALBERT ENAYATI
Regulation Number872.4760
Classification Product Code
JEY  
Subsequent Product Code
HTY  
Date Received03/28/2003
Decision Date 04/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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