VISI-FLOW IRRIGATOR

Irrigator, Ostomy

CONVATEC, A DIVISION OF E.R. SQUIBB & SONS

The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Visi-flow Irrigator.

Pre-market Notification Details

Device IDK832299
510k NumberK832299
Device Name:VISI-FLOW IRRIGATOR
ClassificationIrrigator, Ostomy
Applicant CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeEXD  
CFR Regulation Number876.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-07-13
Decision Date1983-08-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00768455104253 K832299 000

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