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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 K113351
Model 20-0950,20-0900
Device Name CORTRAK ENTERAL ACCESS DEVICE
Original Applicant
CORPAK MEDSYSTEMS
1001 asbury dr.
buffalo grove,  IL  60089
Original Contact stephanie wasielewski
Regulation Number876.5980
Classification Product Code
KNT  
Date Received11/14/2011
Decision Date 01/10/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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