FDA.reportPublic FDA data

510(k) K902138

Device
STRIPE PROJECTOR
Applicant
ACADEMIC CATALYST CORP.
510(k) number
K902138
Product code
HJI  
Decision
Substantially Equivalent (SESE)
Decision date
1990-07-05
Date received
1990-05-10
Regulation
886.1395
Classification name
Lens, Fundus, Hruby, Diagnostic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LAWRENCE KUNSTADT
Address
14 Madison Ave. Valhalla NY US 10595 10595

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HJI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K923670BYRNE EXPULSIVE LENSOcular Instruments, Inc.1992-11-16
K90183960 FUNDUS CAMERA CF-60UVCanon USA, Inc.1990-07-05
K897186LASER IMAGING WORK STATIONInnovision Medical, Inc.1990-03-12
K820223OMS QUARTZ INFUSION CONTACT LENSOptical Micro Systems, Inc.1982-02-05
K802927SEBESTYEN IRRIGATING CONTACT LENSCooper Medical Devices Corp.1981-02-05
K802971LANDERS CONTACT LENSCooper Medical Devices Corp.1981-02-05
K760949CHARLES IRRIGATING FUNDUS CONTACT LENSRichard'S Medical Equip., Inc.1976-11-11

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