510(k) K904469

Device: Eyeopener
Applicant: KC MEDICAL INDUSTRIES
510(k) number: K904469
Product code: JYJ
Decision: Substantially Equivalent (SESE)
Decision date: 1991-06-28
Date received: 1990-10-01
Regulation: 874.4420
Classification name: Gauge, Measuring
Medical specialty: Ear, Nose, Throat
Review panel: Ear, Nose, Throat
Device class: 1
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Contact: JEAN E KEEN
Address: 509 S. Washburn St. Oshkosh WI US 54904 54904

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JYJ#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K884974	ACCESSORY TO EYEDROP GUIDE	Suredrop, Inc.	1989-03-24
K874569	SUREDROP EYEDROP GUIDE	Suredrop, Inc.	1988-05-03
K833606	IMPLANT MEASURING GAUGE	Microtek Medical, Inc.	1984-01-03
K801938	RHINOMETER	Aztec Medical Products, Inc.	1980-09-09