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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 K100288
Device Name NEOMED ENTERAL ONLY EXTENSION SET
Applicant
NEOMED, INC.
717 LAKEGLEN DR.
SUWANEE,  GA  30024
Applicant Contact PENNY NORTHCUTT
Correspondent
NEOMED, INC.
717 LAKEGLEN DR.
SUWANEE,  GA  30024
Correspondent Contact PENNY NORTHCUTT
Regulation Number876.5980
Classification Product Code
KNT  
Date Received02/01/2010
Decision Date 08/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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