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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name insufflator, laparoscopic
510(k) Number K121336
Device Name MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
Original Applicant
SURGIQUEST, INC.
333 quarry rd
milford,  CT  06460
Original Contact daniel donovan
Regulation Number884.1730
Classification Product Code
HIF  
Subsequent Product Code
GCJ  
Date Received05/03/2012
Decision Date 07/03/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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