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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 K010118
Device Name NORMED MANDIBULAR FIXATION 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 Number872.4760
Classification Product Code
JEY  
Date Received01/16/2001
Decision Date 08/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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