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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 K050176
Device Name VORTEX EZ VASCULAR ACCESS PORT
Applicant
Rita Medical Systems, Inc.
1 Horizon Way
Manchester,  GA  31816
Applicant Contact MARY GOSSARD
Correspondent
Rita Medical Systems, Inc.
1 Horizon Way
Manchester,  GA  31816
Correspondent Contact MARY GOSSARD
Regulation Number880.5965
Classification Product Code
LJT  
Date Received01/26/2005
Decision Date 02/25/2005
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
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