SurgiQuest AirSeal IFS System

Insufflator, Laparoscopic

SURGIQUEST, INC.

The following data is part of a premarket notification filed by Surgiquest, Inc. with the FDA for Surgiquest Airseal Ifs System.

Pre-market Notification Details

Device IDK143404
510k NumberK143404
Device Name:SurgiQuest AirSeal IFS System
ClassificationInsufflator, Laparoscopic
Applicant SURGIQUEST, INC. 333 Quarry Rd Milford,  CT  06460
ContactDaniel Donovan
CorrespondentDaniel Donovan
SURGIQUEST, INC. 333 Quarry Rd Milford,  CT  06460
Product CodeHIF  
CFR Regulation Number884.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-28
Decision Date2015-03-20
Summary:summary

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