Peristeen Anal Irrigation System

Tubes, Gastrointestinal (and Accessories)

COLOPLAST A/S

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

Pre-market Notification Details

Device IDK140310
510k NumberK140310
Device Name:Peristeen Anal Irrigation System
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis,  MN  55116
ContactMeg Daniel
CorrespondentBrian Schmidt
COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis,  MN  55411
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-07
Decision Date2015-09-03
Summary:summary

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