PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE

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, Irrigation Accessory Unit, Irrigation Rectal Catheter, System Strap, Irrigation Tube.

Pre-market Notification Details

Device IDK103254
510k NumberK103254
Device Name:PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis,  MN  55411
ContactBrian Schmidt
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 Received2010-11-03
Decision Date2011-01-31
Summary:summary

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