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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K093414
Device Name PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS
Applicant
SMITHS MEDICAL ASD, INC.
1265 GREY FOX ROAD
ST. PAUL,  MN  55112
Applicant Contact RACHELLE PARSONS
Correspondent
SMITHS MEDICAL ASD, INC.
1265 GREY FOX ROAD
ST. PAUL,  MN  55112
Correspondent Contact RACHELLE PARSONS
Regulation Number880.5965
Classification Product Code
LJT  
Date Received11/02/2009
Decision Date 03/01/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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