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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
Device Name CORTRAK ENTERAL ACCESS DEVICE
Applicant
Corpak Medsystems
1001 Asbury Dr.
Buffalo Grove,  IL  60089
Applicant Contact STEPHANIE WASIELEWSKI
Correspondent
Corpak Medsystems
1001 Asbury Dr.
Buffalo Grove,  IL  60089
Correspondent Contact STEPHANIE WASIELEWSKI
Regulation Number876.5980
Classification Product Code
KNT  
Date Received11/14/2011
Decision Date 01/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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