URETERAL DILATOR— 510(k) K840746

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K840746 for URETERAL DILATOR, Substantially Equivalent on 1984-04-13. Applicant: American Edwards Laboratories. Device class: 2.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code KOE
Device class: Class 2
Regulation: 21 CFR 876.5520
Advisory panel: Gastroenterology, Urology
Date received: 1984-01-19
Decision date: 1984-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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