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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 K100526
Device Name AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE
Applicant
KENTEC MEDICAL, INC.
17871 FITCH
IRVINE,  CA  92614 -6001
Applicant Contact KEITH ROOKS
Correspondent
KENTEC MEDICAL, INC.
17871 FITCH
IRVINE,  CA  92614 -6001
Correspondent Contact KEITH ROOKS
Regulation Number876.5980
Classification Product Code
FPD  
Date Received02/24/2010
Decision Date 04/22/2010
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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