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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 K132169
Device Name SURGIQUEST AIRSEAL IFS
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 Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
HIF  
Date Received07/15/2013
Decision Date 08/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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