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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 K172516
Device Name SurgiQuest AIRSEAL iFS System
Applicant
ConMed Corporation
488 Wheelers Farms Road
Milford,  CT  06461
Applicant Contact Lisa Anderson
Correspondent
Daniel & Daniel Consulting, LLC
340 Jones Lane
Gardnerville,  NV  89460
Correspondent Contact Michael Daniel
Regulation Number884.1730
Classification Product Code
HIF  
Subsequent Product Code
GCJ  
Date Received08/21/2017
Decision Date 03/16/2018
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
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