FDA.reportPublic FDA data

510(k) K821084

Device
UNIVERSAL TRIAL FRAMEE
Applicant
MEDICAL EQUIPMENT DESIGNS, INC.
510(k) number
K821084
Product code
HPA  
Decision
Substantially Equivalent (SESE)
Decision date
1982-06-14
Date received
1982-04-19
Regulation
886.1415
Classification name
Frame, Trial, Ophthalmic
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 HPA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K852548ATL 225 MW TRAIL LENS SETAscon Medical Instruments, Ltd.1985-07-31
K852126ATF 101 TRAIL FRAMEAscon Medical Instruments, Ltd.1985-06-05
K841768WOODLYN LIGHTWEIGHT TRIAL FRAMEWoodlyn, Inc.1984-06-01
K833669IMAGE DEFLECTORMichael Onufryk1984-03-27

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