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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 K133203
Device Name SINGLE-SITE PORT
Applicant
Intuitive Surgical, Inc.
1266 Kifer Rd. Bldg. 101
Sunnyvale,  CA  94086
Applicant Contact EINAV YEMINI
Correspondent
Intuitive Surgical, Inc.
1266 Kifer Rd. Bldg. 101
Sunnyvale,  CA  94086
Correspondent Contact EINAV YEMINI
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
NAY  
Date Received10/17/2013
Decision Date 05/09/2014
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
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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