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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 K062414
Device Name VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET
Applicant
Rita Medical Systems, Inc.
One Horizon Way
Manchester,  GA  31816
Applicant Contact DAVID SMITH
Correspondent
Rita Medical Systems, Inc.
One Horizon Way
Manchester,  GA  31816
Correspondent Contact DAVID SMITH
Regulation Number880.5965
Classification Product Code
LJT  
Subsequent Product Code
FPA  
Date Received08/17/2006
Decision Date 02/01/2007
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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