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510(k) K910828

Device
LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS
Applicant
OCULAR INSTRUMENTS, INC.
510(k) number
K910828
Product code
MLP  
Decision
Substantially Equivalent (SESE)
Decision date
1991-08-21
Date received
1991-02-27
Regulation
886.3400
Classification name
Keratoprosthesis, Temporary Implant, Surgical Use
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
TAMSIN J ERICKSON
Address
2255 116th Ave., NE Bellevue WA US 98004 98004

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MLP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K902491ECKHARDT TEMPORARY KERATOPROSTHESISDutch Ophthalmic USA, Inc.1990-06-26
K895013COBO TEMPORARY KERATOPROSTHESISOcular Instruments, Inc.1989-10-31
K842856LANDERS-FOULKS TEMP. KERATOPROSTHESISOcular Instruments, Inc.1984-12-18

Legacy Summary#

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FDA Review#

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