AMIELLE— 510(k) K983045

Substantially Equivalent

Owen Mumford USA, Inc.

FDA 510(k) clearance K983045 for AMIELLE, Substantially Equivalent on 1998-11-25. Applicant: Owen Mumford USA, Inc.. Device class: 2.

Clearance details

Applicant: Owen Mumford USA, Inc.
Product code: Code KXP
Device class: Class 2
Regulation: 21 CFR 884.3900
Advisory panel: Obstetrics/Gynecology
Date received: 1998-09-01
Decision date: 1998-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KXP

K202542 — Allura Vaginal Stent2020-09-30
K974479 — SILIMED VAGINAL STENT1998-08-05
K920633 — PESSARY FLEXIBLE SILICONE NICHOLS1995-11-08

More clearances from Owen Mumford USA, Inc.

K013362 — AUTOJECT 22001-11-13
K993385 — AUTOJET 2 (NON-FIXED NEEDLE TYPE)1999-11-10
K983994 — UNIFINE1999-01-08
K983974 — OWEN MUMFORD 3ML AUTOPEN1998-12-21
K982275 — RAPPORT V.T.D.1998-12-04

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