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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 K162110
Device Name CORGRIP NG/NI Tube Retention System
Applicant
Corpak Medsystems, Inc. A Division of Haylard Health
1001 Asbury Dr.
Buffalo Grove,  IL  60089
Applicant Contact Stephanie Wasielewski
Correspondent
Corpak Medsystems, Inc. A Division of Haylard Health
1001 Asbury Dr.
Buffalo Grove,  IL  60089
Correspondent Contact Stephanie Wasielewski
Regulation Number876.5980
Classification Product Code
KNT  
Date Received07/29/2016
Decision Date 09/15/2016
Decision Substantially Equivalent - Kit (SESK)
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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