AMNIO CENTESES KIT W/NEEDLE— 510(k) K830019

Name: FDA 510(k) clearance K830019
Creator: U.S. Food and Drug Administration
Published: 1983-01-18

Substantially Equivalent

Universal Medical Instrument Corp.

FDA 510(k) clearance K830019 for AMNIO CENTESES KIT W/NEEDLE, Substantially Equivalent on 1983-01-18. Applicant: Universal Medical Instrument Corp.. Device class: 1.

Clearance details

Applicant: Universal Medical Instrument Corp.
Product code: Code HIO
Device class: Class 1
Regulation: 21 CFR 884.1550
Advisory panel: Obstetrics/Gynecology
Date received: 1983-01-04
Decision date: 1983-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.