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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 K801498
Device Name ENTRI NASOGASTRIC FEEDING TUBE
Applicant
BIOSEARCH MEDICAL PRODUCTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BIOSEARCH MEDICAL PRODUCTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5980
Classification Product Code
KNT  
Date Received06/27/1980
Decision Date 07/28/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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