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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Double Lumen For Intestinal Decompression And/Or Intubation
510(k) Number K171619
Device Name 14Fr Colon Decompression Set, Macon Colon Decompression Set
Applicant
Cook Ireland Ltd
O'Halloran Road, National Technology Park
Limerick,  IE
Applicant Contact Laura Graham
Correspondent
Cook Ireland Ltd
O'Halloran Road, National Technology Park
Limerick,  IE
Correspondent Contact Laura Graham
Regulation Number876.5980
Classification Product Code
FEG  
Date Received06/02/2017
Decision Date 08/01/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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