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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 K082710
Device Name SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SET
Applicant
Neochild, LLC
4605 N/ Stiles
Oklahoma City,  OK  73105
Applicant Contact RHETT BOLEN
Correspondent
Neochild, LLC
4605 N/ Stiles
Oklahoma City,  OK  73105
Correspondent Contact RHETT BOLEN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received09/16/2008
Decision Date 01/23/2009
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 Yes
Predetermined Change
Control Plan Authorized		 No
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