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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Tube, Nasogastric
510(k) Number K051480
Device Name ENTERAL FEEDING TUBE
Applicant
Biosearch Medical Products, Inc.
35 Industrial Pkwy.
Branchburg,  NJ  08876
Applicant Contact GENE BOYD
Correspondent
Biosearch Medical Products, Inc.
35 Industrial Pkwy.
Branchburg,  NJ  08876
Correspondent Contact GENE BOYD
Regulation Number876.5980
Classification Product Code
BSS  
Date Received06/03/2005
Decision Date 10/12/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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