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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 K831328
Device Name NEONATAL NASOGASTRIC FEEDING TUBE-
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 Received04/25/1983
Decision Date 07/19/1983
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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