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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, surgical, computer controlled instrument
510(k) Number K183107
Device Name Intuitive Surgical Vessel Sealer Extend
Applicant
Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale,  CA  94086
Applicant Contact Kunal Gunjal
Correspondent
Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale,  CA  94086
Correspondent Contact Kunal Gunjal
Regulation Number876.1500
Classification Product Code
NAY  
Date Received11/08/2018
Decision Date 12/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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