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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 K080918
Device Name DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0
Applicant
Depuy Mitek
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact KRISTINE CHRISTO
Correspondent
Depuy Mitek
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact KRISTINE CHRISTO
Regulation Number878.4840
Classification Product Code
NEW  
Subsequent Product Code
GAT  
Date Received04/01/2008
Decision Date 04/23/2008
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
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