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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 K071571
Device Name SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM
Applicant
SURGIQUEST, INC.
12 CASCADE BLVD.
SUITE 2B
ORANGE,  CT  06477
Applicant Contact KOUROSH AZARBARZIN
Correspondent
SURGIQUEST, INC.
12 CASCADE BLVD.
SUITE 2B
ORANGE,  CT  06477
Correspondent Contact KOUROSH AZARBARZIN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/08/2007
Decision Date 07/30/2007
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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