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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 K992693
FOIA Releasable 510(k) K992693
Device Name RITA MODEL 90 ELECTROSURGICAL ACCESSORY, MODEL 90
Applicant
Rita Medical Systems
967 N. Shoreline Blvd.
Mountain View,  CA  94043
Applicant Contact ERIN DIGNAN
Correspondent
Rita Medical Systems
967 N. Shoreline Blvd.
Mountain View,  CA  94043
Correspondent Contact ERIN DIGNAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/12/1999
Decision Date 09/10/1999
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
Recalls CDRH Recalls
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