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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 K831968
Device Name VIVONEX TUNGSTEN TIP TUBE-BRAIDED
Applicant
NORWICH EATON PHARMACEUTICALS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
NORWICH EATON PHARMACEUTICALS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5980
Classification Product Code
KNT  
Date Received06/20/1983
Decision Date 09/01/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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