Digitex Delivery Device— 510(k) K173527

Substantially Equivalent

Coloplast A/S

FDA 510(k) clearance K173527 for Digitex Delivery Device, Substantially Equivalent on 2018-02-12. Applicant: Coloplast A/S. Device class: 2.

Clearance details

Applicant: Coloplast A/S
Product code: Code PWI
Device class: Class 2
Regulation: 21 CFR 884.4910
Advisory panel: Obstetrics/Gynecology
Date received: 2017-11-14
Decision date: 2018-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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