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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 K023846
Device Name MR COMPATIBLE RITA MODEL 90 ELECTOSURGICAL ACCESSORY
Applicant
RITA MEDICAL SYSTEMS
967 NORTH SHORELINE BLVD.
MOUNTAIN VIEW,  CA  94043
Applicant Contact KAREN FRISCHMEYER
Correspondent
RITA MEDICAL SYSTEMS
967 NORTH SHORELINE BLVD.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact KAREN FRISCHMEYER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/19/2002
Decision Date 12/06/2002
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
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