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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
Applicant
SURGIQUEST, INC.
333 Quarry Rd
Milford,  CT  06460
Applicant Contact DANIEL DONOVAN
Correspondent
SURGIQUEST, INC.
333 Quarry Rd
Milford,  CT  06460
Correspondent 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 (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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