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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tube, feeding
510(k) Number K780415
Device Name VIVONEX DELIVERY SYSTEM
Applicant
NORWICH PHARMACAL CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
NORWICH PHARMACAL CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5980
Classification Product Code
FPD  
Date Received03/14/1978
Decision Date 04/10/1978
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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