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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, surgical, absorbable, polydioxanone
510(k) Number K123668
Device Name ORTHOCORD
Applicant
DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY
325 Paramount Drive
Raynham,  MA  02767
Applicant Contact TATYANA KORSUNSKY
Correspondent
DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY
325 Paramount Drive
Raynham,  MA  02767
Correspondent Contact TATYANA KORSUNSKY
Regulation Number878.4840
Classification Product Code
NEW  
Subsequent Product Code
GAT  
Date Received11/29/2012
Decision Date 02/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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