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..

Clearance details

Applicant: Owen Mumford USA, Inc.
Product code: Code KXP
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 ↗

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