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510(k) K890977

Device
MCINTYRE SURGICAL GONIOLENS
Applicant
OCULAR INSTRUMENTS, INC.
510(k) number
K890977
Product code
HKS  
Decision
Substantially Equivalent (SESE)
Decision date
1989-05-23
Date received
1989-02-27
Regulation
886.1660
Classification name
Prism, Gonioscopic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
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 HKS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K140368FAMILY OF DISPOSABLE LENSESSensor Medical Technology, LLC2014-04-29
K935302OSHER SURGICAL GONIO/POSTERIOR POLE LENSOcular Instruments, Inc.1994-04-01
K895846TWO MIRROR GONIO LENSOcular Instruments, Inc.1989-12-18
K862692KARICKHOFF DIAGNOSTIC/LASER LENSOcular Instruments, Inc.1986-08-21
K862713ABRAHAM IRIDECTOMY LENS (YAG LASER)Ocular Instruments, Inc.1986-08-21
K862024SUSSMAN FOUR MIRROR HAND HELD GONIOPRISMOcular Instruments, Inc.1986-07-11
K862512RITCH TRABECULOPLASTY LASER LENSOcular Instruments, Inc.1986-07-11
K861027KETA HAND-HELD TONOMETERKeta Corp.1986-05-06
K830169DORC ADJUSTABLE IMAGE CONTACTSJedmed Instrument Co.1983-02-07

Legacy Summary#

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FDA Review#

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