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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 K120403
Device Name SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER
Original Applicant
TRANSENTERIX, INC.
635 davis drive suite 300
durham,  NC  27560
Original Contact tammy b carrea
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/09/2012
Decision Date 04/16/2012
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
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