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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 K072657
Device Name POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS
Applicant
SMITHS MEDICAL MD, INC.
1265 GREY FOX RD.
ARDEN HILLS,  MN  55112
Applicant Contact BRIAN HAUGSTAD
Correspondent
SMITHS MEDICAL MD, INC.
1265 GREY FOX RD.
ARDEN HILLS,  MN  55112
Correspondent Contact BRIAN HAUGSTAD
Regulation Number880.5965
Classification Product Code
LJT  
Subsequent Product Code
FPA  
Date Received09/20/2007
Decision Date 12/14/2007
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
Recalls CDRH Recalls
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