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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 K031257
Device Name RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR
Applicant
RITA MEDICAL SYSTEMS INC
967 N. SHORELINE BLVD.
MOUNTAIN VIEW,  CA  94043
Applicant Contact VICKI HACKER
Correspondent
UNDERWRITERS LABORATORIES, INC.
2600 NW LAKE RD.
CAMAS,  WA  98607 -9526
Correspondent Contact CHARLES MACK
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/21/2003
Decision Date 05/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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