OSTOMY IRRIGATION SET

Irrigator, Ostomy

COLOPLAST A/S

The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Ostomy Irrigation Set.

Pre-market Notification Details

Device IDK121833
510k NumberK121833
Device Name:OSTOMY IRRIGATION SET
ClassificationIrrigator, Ostomy
Applicant COLOPLAST A/S 1601 WEST RIVER ROAD N Minneapolis,  MN  55411
ContactTim Crabtree
CorrespondentTim Crabtree
COLOPLAST A/S 1601 WEST RIVER ROAD N Minneapolis,  MN  55411
Product CodeEXD  
CFR Regulation Number876.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-06-22
Decision Date2012-07-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05708932027953 K121833 000

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