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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic tissue approximation device
510(k) Number K172775
Device Name MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
Applicant
Teleflex Medical, Inc.
3015 Carrington Mill Blvd
Morrisville,  NC  27560
Applicant Contact Holly Hallock
Correspondent
Teleflex Medical, Inc.
3015 Carrington Mill Blvd
Morrisville,  NC  27560
Correspondent Contact Holly Hallock
Regulation Number876.1500
Classification Product Code
OCW  
Subsequent Product Code
GEI  
Date Received09/14/2017
Decision Date 02/12/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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