FDA.reportPublic FDA data

510(k) K813548

Device
UVEX MINI-SPECS
Applicant
BACOU USA, INC. AND UVEX SAFETY, INC.
510(k) number
K813548
Product code
HOI  
Decision
Substantially Equivalent (SESE)
Decision date
1982-03-02
Date received
1981-12-21
Regulation
886.5840
Classification name
Spectacle, Magnifying
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HOI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K943613NILSing Wah International Enterprises , Ltd.1994-09-21
K930435SPECTACLE FRAMESVenis DI A. Vendrame1993-09-20
K931328PYRAMID SUNGLASSES/PYRAMID READING GLASSESPyramid1993-08-10
K910329SUNGLASSESCutler & Gross Sloan Optical , Ltd.1991-03-12
K854854SYSTEMS OF SIGHT LOW VISION EYEWAREInt'L Eye Care, Inc.1986-02-04
K844716MAGNIFYING SPECTACLES W/PLASTIC LENSESGazelle Corp.1985-01-03
K844038VISITEC MAGNIFYING SPECTACLESVisitec Co.1984-11-29
K842835BRILLETTE MODELCillus Company, Inc.1984-11-21
K820732LA VEL LATERAL VIEW EXTENSION LENSPeter M. Tolliver1982-05-03
K801733FENZL RETICLERobert E. Fenzl, M.D.1980-09-16

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases