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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 K010060
Device Name RITA STARBURST XLI ELECTROSURGICAL DEVICE
Applicant
Rita Medical Systems
967 N. Shoreline Blvd.
Mountain View,  CA  94043
Applicant Contact ERIN MAZZONE
Correspondent
Underwriters Laboratories, Inc.
1655 Scott Blvd.
Santa Clara,  CA  95050
Correspondent Contact MICHAEL KWAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/08/2001
Decision Date 01/23/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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