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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Feeding
510(k) Number K082238
Device Name NEOMED POLYURETHANE FEEDING TUBE
Applicant
Neomed, Inc.
717 Lakeglen Dr.
Swanee,  GA  30024
Applicant Contact PENNY NORTHCUTT
Correspondent
Neomed, Inc.
717 Lakeglen Dr.
Swanee,  GA  30024
Correspondent Contact PENNY NORTHCUTT
Regulation Number876.5980
Classification Product Code
FPD  
Subsequent Product Code
BSS  
Date Received08/07/2008
Decision Date 10/01/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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