SILICONE MALE EXTERNAL CATHETER— 510(k) K913524

Substantially Equivalent

Mentor Corp.

FDA 510(k) clearance K913524 for SILICONE MALE EXTERNAL CATHETER, Substantially Equivalent on 1991-10-04. Applicant: Mentor Corp.. Device class: 1.

Clearance details

Applicant: Mentor Corp.
Product code: Code EXJ
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1991-08-08
Decision date: 1991-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EXJ

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K963265 — PROSYS SAMEC LA1996-10-25
K962900 — SELF RETAINING MALE EXTERNAL URINARY CATHETER1996-09-16

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