OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE— 510(k) K920431

Name: FDA 510(k) clearance K920431
Creator: U.S. Food and Drug Administration
Published: 1992-05-29

Substantially Equivalent

Omnitron Intl., Inc.

FDA 510(k) clearance K920431 for OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE, Substantially Equivalent on 1992-05-29. Applicant: Omnitron Intl., Inc.. Device class: 2.

Clearance details

Applicant: Omnitron Intl., Inc.
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 1992-02-03
Decision date: 1992-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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