DND 101— 510(k) K001590

Substantially Equivalent

Urogyn , Ltd.

FDA 510(k) clearance K001590 for DND 101, Substantially Equivalent on 2000-08-02. Applicant: Urogyn , Ltd.. Device class: 2.

Clearance details

Applicant: Urogyn , Ltd.
Product code: Code KNA
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2000-05-17
Decision date: 2000-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick, MA, 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.