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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
Model 9000059 G2
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 (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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