NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES

Tubes, Gastrointestinal (and Accessories)

NEOMED, INC.

The following data is part of a premarket notification filed by Neomed, Inc. with the FDA for Neomed Gastrointestinal Tube And Accessories.

Pre-market Notification Details

Device IDK120182
510k NumberK120182
Device Name:NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant NEOMED, INC. 717 LAKEGLEN DR. Suwanee,  GA  30024
ContactPenny Northcutt
CorrespondentPenny Northcutt
NEOMED, INC. 717 LAKEGLEN DR. Suwanee,  GA  30024
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-20
Decision Date2012-04-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20350770002563 K120182 000
00350770001029 K120182 000
00350770001012 K120182 000
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00350770000992 K120182 000
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00350770000923 K120182 000
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00350770002552 K120182 000
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20350770002501 K120182 000
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00350770002477 K120182 000
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00350770002446 K120182 000
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20350770002426 K120182 000
00350770002415 K120182 000
00350770000886 K120182 000

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