GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY

Tubes, Gastrointestinal (and Accessories)

APPLIED MEDICAL TECHNOLOGIES

The following data is part of a premarket notification filed by Applied Medical Technologies with the FDA for Gastranimal Percutaneous Replacement Gastroomy.

Pre-market Notification Details

Device IDK923488
510k NumberK923488
Device Name:GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant APPLIED MEDICAL TECHNOLOGIES 6100 WEST CREEK RD. SUITE 25 Independence,  OH  44131
ContactDonna Bressan
CorrespondentDonna Bressan
APPLIED MEDICAL TECHNOLOGIES 6100 WEST CREEK RD. SUITE 25 Independence,  OH  44131
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-15
Decision Date1995-07-20

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