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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 K143404
Device Name SurgiQuest AirSeal iFS System
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 Number884.1730
Classification Product Code
HIF  
Subsequent Product Code
GCJ  
Date Received11/28/2014
Decision Date 03/20/2015
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
Predetermined Change
Control Plan Authorized		 No
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