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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 K102646
Device Name SPIDER FLEX MONOPOLAR HOOK
Applicant
Transenterix, Inc.
635 Davis Dr., Suite 300
Morrisville,  NC  27560
Applicant Contact BOBBI L HADERSBECK
Correspondent
Transenterix, Inc.
635 Davis Dr., Suite 300
Morrisville,  NC  27560
Correspondent Contact BOBBI L HADERSBECK
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/14/2010
Decision Date 11/03/2010
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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