IR-192 IMPLANT, MODIFICATION— 510(k) K915253

Name: FDA 510(k) clearance K915253
Creator: U.S. Food and Drug Administration
Published: 1992-02-27

Substantially Equivalent

Omnitron Intl., Inc.

FDA 510(k) clearance K915253 for IR-192 IMPLANT, MODIFICATION, Substantially Equivalent on 1992-02-27. Applicant: Omnitron Intl., Inc.. Device class: 2.

Clearance details

Applicant: Omnitron Intl., Inc.
Product code: Code IWA
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 1991-11-18
Decision date: 1992-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lajke Charles, LA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IWA

view all

K894409 — CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD1989-09-29
K874895 — IR-192 IMPLANT1988-02-25
K850382 — IRIDIUM SEEDS1985-08-15
K844248 — IR-192 IMPLANT1985-04-10
K850163 — IRIDIUM 192 WIRES1985-03-26

More clearances from Omnitron Intl., Inc.

view all

K901615 — PULMOCATH INTRABRONCHIAL CATHETER1992-11-27
K923130 — IR-192 IMPLANT -- MODIFICATION1992-09-21
K920431 — OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE1992-05-29
K913908 — OMNITRON GYN APPLICATOR SYSTEM1992-03-06
K911775 — OMNICATH IMPLANTED CATHETER AND DEPOT1991-05-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.