OES UROLOGY— 510(k) K950719

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K950719 for OES UROLOGY, Substantially Equivalent on 1996-12-11. Applicant: Olympus America, Inc.. Device class: 2.

Clearance details

Applicant: Olympus America, Inc.
Product code: Code EZO
Device class: Class 2
Regulation: 21 CFR 876.4770
Advisory panel: Gastroenterology, Urology
Date received: 1995-02-16
Decision date: 1996-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

Download summary PDF View on FDA.gov ↗

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