Low Profile Non-Balloon Feeding Device

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 Low Profile Non-balloon Feeding Device.

Pre-market Notification Details

Device IDK170319
510k NumberK170319
Device Name:Low Profile Non-Balloon Feeding Device
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant APPLIED MEDICAL TECHNOLOGY INC. 8006 KATHERINE BOULEVARD Brecksville,  OH  44141
ContactShraddha Saini
CorrespondentShraddha Saini
APPLIED MEDICAL TECHNOLOGY INC. 8006 KATHERINE BOULEVARD Brecksville,  OH  44141
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-01
Decision Date2017-10-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842071132156 K170319 000
00842071132057 K170319 000
00842071132064 K170319 000
00842071132071 K170319 000
00842071132088 K170319 000
00842071132095 K170319 000
00842071132101 K170319 000
00842071132118 K170319 000
00842071132125 K170319 000
00842071132132 K170319 000
00842071132149 K170319 000
00842071132040 K170319 000

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