CONVEEN(R) LEG BAG(500 ML)— 510(k) K924406

Substantially Equivalent

Coloplast A/S

FDA 510(k) clearance K924406 for CONVEEN(R) LEG BAG(500 ML), Substantially Equivalent on 1992-10-30. Applicant: Coloplast A/S. Device class: 1.

Clearance details

Applicant: Coloplast A/S
Product code: Code FAQ
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1992-08-25
Decision date: 1992-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Woth, TX, 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.