AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM

Tubes, Gastrointestinal (and Accessories)

APPLIED MEDICAL TECHNOLOGY, INC.

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

Pre-market Notification Details

Device IDK042300
510k NumberK042300
Device Name:AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant APPLIED MEDICAL TECHNOLOGY, INC. 15653 NEO PKWY. Cleveland,  OH  44128
ContactChris Zantopulos
CorrespondentChris Zantopulos
APPLIED MEDICAL TECHNOLOGY, INC. 15653 NEO PKWY. Cleveland,  OH  44128
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-08-24
Decision Date2004-10-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842071111809 K042300 000
00842071111793 K042300 000
00842071130626 K042300 000
00842071131173 K042300 000

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