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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 K103692
FOIA Releasable 510(k) K103692
Device Name SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
Applicant
SURGIQUEST, INC.
12 CASCADE BLVD.
SUITE 2B
ORANGE,  CT  06477
Applicant Contact DANIEL DONOVAN
Correspondent
SURGIQUEST, INC.
12 CASCADE BLVD.
SUITE 2B
ORANGE,  CT  06477
Correspondent Contact DANIEL DONOVAN
Regulation Number884.1730
Classification Product Code
HIF  
Subsequent Product Code
GCJ  
Date Received12/17/2010
Decision Date 05/25/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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