CORDGUARD II— 510(k) K954619

Substantially Equivalent

Utah Medical Products, Inc.

FDA 510(k) clearance K954619 for CORDGUARD II, Substantially Equivalent on 1995-12-21. Applicant: Utah Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Utah Medical Products, Inc.
Product code: Code KNA
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1995-10-05
Decision date: 1995-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Midvale, UT, 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.