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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 K091637
Device Name CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
Applicant
CORPAK MEDSYSTEMS
100 CHADDICK DR.
WHEELING,  IL  60090
Applicant Contact STEPHANIE WASIELEWSKI
Correspondent
CORPAK MEDSYSTEMS
100 CHADDICK DR.
WHEELING,  IL  60090
Correspondent Contact STEPHANIE WASIELEWSKI
Regulation Number876.5980
Classification Product Code
KNT  
Date Received06/04/2009
Decision Date 09/29/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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