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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 K022035
Device Name OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB
Applicant
Osteomedics, Inc.
809 Carter Ln.
Paramus,  NJ  07652
Applicant Contact ALBERT ENYATI
Correspondent
Osteomedics, Inc.
809 Carter Ln.
Paramus,  NJ  07652
Correspondent Contact ALBERT ENYATI
Regulation Number872.4760
Classification Product Code
JEY  
Date Received06/21/2002
Decision Date 01/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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