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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 K051102
Device Name OMNIPICC PI
Applicant
Rita Medical Systems, Inc.
1 Horizon Way
Manchester,  GA  31816
Applicant Contact DAVID SMITH
Correspondent
Rita Medical Systems, Inc.
1 Horizon Way
Manchester,  GA  31816
Correspondent Contact DAVID SMITH
Regulation Number880.5970
Classification Product Code
LJS  
Date Received04/29/2005
Decision Date 11/23/2005
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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