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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 K022323
Device Name NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM
Applicant
OSTEOMEDICS, INC.
809 CARTER LN.
PARAMUS,  NJ  07652
Applicant Contact ALBERT ENAYATI
Correspondent
OSTEOMEDICS, INC.
809 CARTER LN.
PARAMUS,  NJ  07652
Correspondent Contact ALBERT ENAYATI
Regulation Number888.3030
Classification Product Code
HRS  
Date Received07/17/2002
Decision Date 09/09/2002
Decision Substantially Equivalent (SESE)
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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