FDA.reportPublic FDA data

510(k) K853758

Device
PY-RITE
Applicant
GOLDEN DENTAL PRODUCTS, INC.
510(k) number
K853758
Product code
NJH  
Decision
Substantially Equivalent (SESE)
Decision date
1985-12-03
Date received
1985-09-09
Regulation
886.5844
Classification name
Lens, Spectacle (prescription), For Reading Discomfort
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DON WHITE
Address
16000 W. 76th. Ave. Golden CO US 80403 80403

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NJH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K022373CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENSCantor & Nissel , Ltd.2002-10-07

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