GELPOINT PATH— 510(k) K110792

Substantially Equivalent

Applied Medical Resources Corp.

FDA 510(k) clearance K110792 for GELPOINT PATH, Substantially Equivalent on 2011-05-23. Applicant: Applied Medical Resources Corp.. Device class: 2.

Clearance details

Applicant: Applied Medical Resources Corp.
Product code: Code FER
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2011-03-21
Decision date: 2011-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Santa, CA, 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.