AMT Suture Delivery System

Tube, Gastro-enterostomy

Applied Medical Technology, Inc.

The following data is part of a premarket notification filed by Applied Medical Technology, Inc. with the FDA for Amt Suture Delivery System.

Pre-market Notification Details

Device IDK193612
510k NumberK193612
Device Name:AMT Suture Delivery System
ClassificationTube, Gastro-enterostomy
Applicant Applied Medical Technology, Inc. 8006 Katherine Blvd. Brecksville,  OH  44141
ContactJoy Tubero
CorrespondentJoy Tubero
Applied Medical Technology, Inc. 8006 Katherine Blvd. Brecksville,  OH  44141
Product CodeKGC  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
510k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-26
Decision Date2020-03-12

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