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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 K032047
Device Name TRI-LOOP MICROWAVE ABLATION PROBE
Applicant
Vivant Medical, Inc.
1916-A Old Middlefield Way
Mountain View,  CA  94043
Applicant Contact STEVEN KIM
Correspondent
Vivant Medical, Inc.
1916-A Old Middlefield Way
Mountain View,  CA  94043
Correspondent Contact STEVEN KIM
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/02/2003
Decision Date 08/06/2003
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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