FDA.reportPublic FDA data

510(k) K871646

Device
TANNE CORNEAL CUTTING BLOCK
Applicant
OCULAR INSTRUMENTS, INC.
510(k) number
K871646
Product code
HNJ  
Decision
Substantially Equivalent (SESE)
Decision date
1987-05-18
Date received
1987-04-28
Regulation
886.4350
Classification name
Punch, Corneo-scleral
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
TAMSIN J ERICKSON
Address
12100 Northup Way Suite D Bellevue WA US 98005 98005

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HNJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K830335DORC CORNEAL PUNCH BLOCKJedmed Instrument Co.1983-03-09
K791988REPL. PISTON FOR TROUTMAN CORNEAL PUNCHEdward Weck, Inc.1979-10-30

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