O'REGAN LIGATOR— 510(k) K963166

Substantially Equivalent

Patrick J. O'Regan

FDA 510(k) clearance K963166 for O'REGAN LIGATOR, Substantially Equivalent on 1997-05-05. Applicant: Patrick J. O'Regan. Device class: 2.

Clearance details

Applicant: Patrick J. O'Regan
Product code: Code FHN
Device class: Class 2
Regulation: 21 CFR 876.4400
Advisory panel: Gastroenterology, Urology
Date received: 1996-08-14
Decision date: 1997-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, CA

Download summary PDF View on FDA.gov ↗

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