URETERAL ILLUMINATOR— 510(k) K941506

Substantially Equivalent

Apple Medical Corp.

FDA 510(k) clearance K941506 for URETERAL ILLUMINATOR, Substantially Equivalent on 1994-10-05. Applicant: Apple Medical Corp.. Device class: 2.

Clearance details

Applicant: Apple Medical Corp.
Product code: Code FCS
Device class: Class 2
Regulation: 21 CFR 876.4020
Advisory panel: Gastroenterology, Urology
Date received: 1994-03-29
Decision date: 1994-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bolton, MA, 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.