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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 K060036
Device Name PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE VENOUS ACCESS SYSTEMS WITH DUAL LAYER CATHETER
Applicant
SMITHS MEDICAL MD, INC.
1265 GREY FOX RD.
ST. PAUL,  MN  55112
Applicant Contact MELANIE HESS
Correspondent
SMITHS MEDICAL MD, INC.
1265 GREY FOX RD.
ST. PAUL,  MN  55112
Correspondent Contact MELANIE HESS
Regulation Number880.5965
Classification Product Code
LJT  
Date Received01/05/2006
Decision Date 05/17/2006
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
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