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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K152663
Device Name Bladeless Optical Obturators
Applicant
Intuitive Surgical, Inc.
1266 Kifer Rd.
Suunyvale,  CA  94086
Applicant Contact VISHAL KANANI
Correspondent
Intuitive Surgical, Inc.
1266 Kifer Rd.
Suunyvale,  CA  94086
Correspondent Contact VISHAL KANANI
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/17/2015
Decision Date 10/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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