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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 K092504
Device Name SURGIQUEST AIRSEAL OPTICAL TROCAR AND 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 Received08/14/2009
Decision Date 11/05/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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