AMT T-FASTENER ANCHOR KIT

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 T-fastener Anchor Kit.

Pre-market Notification Details

Device IDK120587
510k NumberK120587
Device Name:AMT T-FASTENER ANCHOR KIT
ClassificationTube, Gastro-enterostomy
Applicant APPLIED MEDICAL TECHNOLOGY, INC. 8000 KATHERINE BOULEVARD Brecksville,  OH  44141
ContactElizabeth Meyer
CorrespondentElizabeth Meyer
APPLIED MEDICAL TECHNOLOGY, INC. 8000 KATHERINE BOULEVARD Brecksville,  OH  44141
Product CodeKGC  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-27
Decision Date2012-05-25

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