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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 K873343
Device Name ENTUBE-MEER AND MEER FEEDING TUBE BRIDLE SYSTEM
Applicant
ENTECH, INC.
ROUTE 22 EAST
LEBANON,  NJ  08833
Applicant Contact LAURENCE A POTTER
Correspondent
ENTECH, INC.
ROUTE 22 EAST
LEBANON,  NJ  08833
Correspondent Contact LAURENCE A POTTER
Regulation Number876.5980
Classification Product Code
KNT  
Date Received08/19/1987
Decision Date 12/07/1987
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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