UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE— 510(k) K844558

Name: FDA 510(k) clearance K844558
Creator: U.S. Food and Drug Administration
Published: 1985-01-31

Substantially Equivalent

Universal Medical Instrument Corp.

FDA 510(k) clearance K844558 for UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE, Substantially Equivalent on 1985-01-31. 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: 1984-11-21
Decision date: 1985-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ballston Spa, NY, US

Download summary PDF View on FDA.gov ↗

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