OSTOMY IRRIGATION SET— 510(k) K121833

Substantially Equivalent

Coloplast A/S

FDA 510(k) clearance K121833 for OSTOMY IRRIGATION SET, Substantially Equivalent on 2012-07-16. Applicant: Coloplast A/S. Device class: 2.

Clearance details

Applicant: Coloplast A/S
Product code: Code EXD
Device class: Class 2
Regulation: 21 CFR 876.5895
Advisory panel: Gastroenterology, Urology
Date received: 2012-06-22
Decision date: 2012-07-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EXD

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K904586 — PALEX IRRIGATION SET1990-12-28
K871791 — BLOXOM IRRIGATOR1987-05-20
K840268 — IRRIGATION SYSTEM1984-04-05
K832299 — VISI-FLOW IRRIGATOR1983-08-26

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Data sourced from openFDA. This site is unofficial and independent of the FDA.