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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 K100180
Device Name SURGIQUEST ANCHORPORT SIL KIT
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 Received01/21/2010
Decision Date 05/05/2010
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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