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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K062579
Device Name OMNIPICC P.I.
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 Number880.5970
Classification Product Code
LJS  
Date Received08/31/2006
Decision Date 11/28/2006
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
Predetermined Change
Control Plan Authorized		 No
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