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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 K102839
Device Name SPIDER STANDARD AND ADVANCED
Applicant
TRANSENTERIX, INC.
635 DAVIS DRIVE SUITE 300
MORRISVILLE,  NC  27560
Applicant Contact BOBBI L HADERSBECK
Correspondent
TRANSENTERIX, INC.
635 DAVIS DRIVE SUITE 300
MORRISVILLE,  NC  27560
Correspondent Contact BOBBI L HADERSBECK
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
OTJ  
Date Received09/29/2010
Decision Date 03/15/2011
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
Recalls CDRH Recalls
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