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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 K943675
Device Name ENTERAL DELIVERY SETS WITH HYDRATION PORT
Applicant
CLINTEC TECHNOLOGIES, INC.
THREE PARKWAY NORTH, SUITE 200
P.O. BOX 760
DEERFIELS,  IL  60015
Applicant Contact DENNIS OCWIEJA
Correspondent
CLINTEC TECHNOLOGIES, INC.
THREE PARKWAY NORTH, SUITE 200
P.O. BOX 760
DEERFIELS,  IL  60015
Correspondent Contact DENNIS OCWIEJA
Regulation Number876.5980
Classification Product Code
KNT  
Date Received07/26/1994
Decision Date 12/30/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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