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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name irrigator, ostomy
510(k) Number K832299
Device Name VISI-FLOW IRRIGATOR
Applicant
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5895
Classification Product Code
EXD  
Date Received07/13/1983
Decision Date 08/26/1983
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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