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510(k) K875114

Device
HOSKINS-BARKAN GONIOTOMY LENS 9MM
Applicant
OCULAR INSTRUMENTS, INC.
510(k) number
K875114
Product code
HJK  
Decision
Substantially Equivalent (SESE)
Decision date
1988-02-19
Date received
1987-12-14
Regulation
886.1385
Classification name
Lens, Contact, Polymethylmethacrylate, Diagnostic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
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 HJK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K201909RxSight Contact LensRxsight, Inc.2020-09-10
K173944Endocular Viewing Lenses and Silicone RingPhakos2018-10-25
K151961Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensVolk Optical, Inc.2015-08-18
K142715Sensor Medical Family of Vitrectomy Lenses and ProductsSensor Medical Technology, LLC2014-12-16
K051630SUPER VIEW DISPOSABLE BIOM LENS SETInsight Instruments, Inc.2005-06-29
K051103HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORYHaag-Streit USA, Inc.2005-06-07
K050623VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV DVolk Optical, Inc.2005-03-28
K033950DORC VITRECTOMY LENSES, MODEL 1284 SERIESDutch Ophthalmic Research Center (D.O.R.C.)2004-02-20
K030054DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSESFci Ophthalmics, Inc.2003-02-26
K023221CONTACT LASER & DIAGNOSTIC LENSESVolk Optical, Inc.2002-10-11
K022413LUNEAU 3 MIRROR LENSLuneau SA2002-09-24
K014170STAURENGHI WIDE FIELD SCANNING LASER LENSOcular Instruments, Inc.2002-03-04
K012096DISPOSABLE VITRECTOMY LENSOcular Instruments, Inc.2001-08-24
K971853ENDOVIEW SPPHIRE LENS SETAmerican Medical Devices, Inc.1997-08-06
K933976MANDELKORN SUTURE LYSIS LENSOcular Instruments, Inc.1994-11-08

Legacy Summary#

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FDA Review#

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