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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Accessories, Pump, Infusion
510(k) Number K030936
Device Name RITA CLIPS FOR INFUSION PUMPS
Applicant
Rita Medical Systems, Inc.
967 N. Shoreline Blvd.
Mountain View,  CA  94043
Applicant Contact VICKI HACKER
Correspondent
Underwriters Laboratories, Inc.
1655 Scott Blvd.
Santa Clara,  CA  95050
Regulation Number880.5725
Classification Product Code
MRZ  
Date Received03/25/2003
Decision Date 04/01/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized
No
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