ONAT BALLOONED NASOGASTRIC TUBE

Tubes, Gastrointestinal (and Accessories)

MACDONALD MEDICAL DEVICES, INC.

The following data is part of a premarket notification filed by Macdonald Medical Devices, Inc. with the FDA for Onat Ballooned Nasogastric Tube.

Pre-market Notification Details

Device IDK920262
510k NumberK920262
Device Name:ONAT BALLOONED NASOGASTRIC TUBE
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant MACDONALD MEDICAL DEVICES, INC. 611 WEST JOHNSON AVE. Cheshire,  CT  06410 -1125
ContactEric N Randall
CorrespondentEric N Randall
MACDONALD MEDICAL DEVICES, INC. 611 WEST JOHNSON AVE. Cheshire,  CT  06410 -1125
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-01-21
Decision Date1993-04-20

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