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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 K043298
Device Name BLUE ORTHOCORD SUTURE
Applicant
Depuy Mitek
249 VANDERBILT DR.
NORWOOD,  MA  02062
Applicant Contact RUTH C FORSTADT
Correspondent
Depuy Mitek
249 VANDERBILT DR.
NORWOOD,  MA  02062
Correspondent Contact RUTH C FORSTADT
Regulation Number878.4840
Classification Product Code
NEW  
Date Received11/30/2004
Decision Date 12/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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