TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE— 510(k) K864219

Name: FDA 510(k) clearance K864219
Creator: U.S. Food and Drug Administration
Published: 1987-03-27

Substantially Equivalent

Amedic USA

FDA 510(k) clearance K864219 for TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE, Substantially Equivalent on 1987-03-27. Applicant: Amedic USA. Device class: 2.

Clearance details

Applicant: Amedic USA
Product code: Code HGL
Device class: Class 2
Regulation: 21 CFR 884.2960
Advisory panel: Obstetrics/Gynecology
Date received: 1986-10-28
Decision date: 1987-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

Download summary PDF View on FDA.gov ↗

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