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510(k) K032422

Device
EUSOL-C
Applicant
AL.CHI.MI.A
510(k) number
K032422
Product code
LYX  
Decision
Substantially Equivalent (SESE)
Decision date
2003-12-15
Date received
2003-08-05
Regulation
510(k) Premarket Notification
Classification name
Media, Corneal Storage
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Ophthalmic
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GEORGE MYERS
Address
377 Rte. 17s Hasbrouck Heights NJ US 07604 07604

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LYX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251320XTRA4Al.Chi.Mi.A. S.R.L2025-09-11
K221759CornisolAurolab2022-10-05
K211786Independent Corneal Viewing Chamber (IVC-21)Bausch + Lomb, Incorporated2021-12-03
K162013Eusol-CAl.Chi.Mi.A. S.R.L2016-09-15
K151061Cornea ColdEurobio2015-08-06
K063304LIFE4CNumedis, Inc.2007-12-21
K063617EUSOL-CAl.Chi.Mi.A2007-02-08
K954548THE CHEN MEDIUMChen Ophthalmic Laboratories1996-05-20
K924165OPTISOL-GS CORNEAL STORAGE MEDIAChiron Intraoptics1992-10-06
K921728DEXSOL CORNEAL STORAGE MEDIA CONTAINER, MODIFIEDChiron Intraoptics1992-06-09
K921729OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIEDChiron Intraoptics1992-06-09
K894162OPTISOLChiron Ophthalmics1990-01-12
K883854DEXSOLNorthern Scientific, Inc.1988-11-16
K870249MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUMBioclinical Laboratory Services, Inc.1987-04-06
K870250MODIFIED MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUMBioclinical Laboratory Services, Inc.1987-04-06

Legacy Summary#

summary

FDA Review#

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