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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 K133167
Device Name MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORD
Applicant
Intuitive Surgical, Inc.
1266 Kifer Rd.
Suunyvale,  CA  94086
Applicant Contact BRANDON HANSEN
Correspondent
Intuitive Surgical, Inc.
1266 Kifer Rd.
Suunyvale,  CA  94086
Correspondent Contact BRANDON HANSEN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/17/2013
Decision Date 01/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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