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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 K133845
Device Name 8MM TROCAR KIT
Applicant
INTUITIVE SURGICAL
1266 KIFER ROAD
SUNNYVALE,  CA  94086
Applicant Contact BRANDON HANSEN
Correspondent
INTUITIVE SURGICAL
1266 KIFER ROAD
SUNNYVALE,  CA  94086
Correspondent Contact BRANDON HANSEN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/18/2013
Decision Date 02/19/2014
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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