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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K030967
Device Name RITA STARBURST SDE ELECTROSURGICAL DEVICE
Applicant
Rita Medical Systems
967 N. Shoreline Blvd.
Mountain View,  CA  94043
Applicant Contact ERIN MAZZONE
Correspondent
Rita Medical Systems
967 N. Shoreline Blvd.
Mountain View,  CA  94043
Correspondent Contact ERIN MAZZONE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/26/2003
Decision Date 04/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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