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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 K120272
Device Name AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET
Applicant
Kentec Medical, Inc.
17871 Fitch
Irvine,  CA  92614 -6001
Applicant Contact KEITH ROOKS
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number876.5980
Classification Product Code
KNT  
Date Received01/30/2012
Decision Date 02/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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