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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, gastrointestinal (and accessories)
510(K) Number K120182
Models FTM5.0V-EO, FTM8.0V-EO, FTS5.0V-EO, FTS8.0V-EO
Device Name NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES
Applicant
NEOMED, INC.
717 lakeglen dr.
suwanee,  GA  30024
Contact penny northcutt
Regulation Number876.5980
Classification Product Code
KNT  
Date Received01/20/2012
Decision Date 04/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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