AMT DECOMPRESSION TUBES

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 Decompression Tubes.

Pre-market Notification Details

Device IDK980145
510k NumberK980145
Device Name:AMT DECOMPRESSION TUBES
ClassificationTube, Gastro-enterostomy
Applicant APPLIED MEDICAL TECHNOLOGY, INC. 15653 NEO PKWY. Cleveland,  OH  44128
ContactThomas W Parkinson
CorrespondentThomas W Parkinson
APPLIED MEDICAL TECHNOLOGY, INC. 15653 NEO PKWY. Cleveland,  OH  44128
Product CodeKGC  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-15
Decision Date1998-04-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842071131760 K980145 000
00842071131784 K980145 000
00842071131463 K980145 000
00842071131807 K980145 000
00842071131814 K980145 000
00842071131821 K980145 000
00842071131838 K980145 000
00842071131845 K980145 000
00842071131852 K980145 000
00842071131777 K980145 000

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