EYEOPENER— 510(k) K904469

Substantially Equivalent

Kc Medical Industries

FDA 510(k) clearance K904469 for EYEOPENER, Substantially Equivalent on 1991-06-28. Applicant: Kc Medical Industries. Device class: 1.

Clearance details

Applicant: Kc Medical Industries
Product code: Code JYJ
Device class: Class 1
Regulation: 21 CFR 874.4420
Advisory panel: Ear, Nose, Throat
Date received: 1990-10-01
Decision date: 1991-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oshkosh, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JYJ

K884974 — ACCESSORY TO EYEDROP GUIDE1989-03-24
K874569 — SUREDROP EYEDROP GUIDE1988-05-03
K833606 — IMPLANT MEASURING GAUGE1984-01-03
K801938 — RHINOMETER1980-09-09

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