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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Umbilical Artery
510(k) Number K130725
Device Name MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.
Applicant
Covidien Lp, Formerly Registered AS Kendall
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact DOLLY MISTRY
Correspondent
Covidien Lp, Formerly Registered AS Kendall
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact DOLLY MISTRY
Regulation Number880.5200
Classification Product Code
FOS  
Date Received03/18/2013
Decision Date 04/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
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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