FDA.reportPublic FDA data

510(k) K925606

Device
OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS
Applicant
CHIRON VISION CORP.
510(k) number
K925606
Product code
HMR  
Decision
Substantially Equivalent (SESE)
Decision date
1994-08-29
Date received
1992-11-05
Regulation
886.4570
Classification name
Marker, Ocular
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CAROL L PATTERSON
Address
9342 Jeronimo Rd. Irvine CA US 92618 92618

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HMR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K053475OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450Refractec, Inc.2006-03-03
K872747LASER CENTERING DEVICEInnomed Corp.1987-09-04
K863663OPHTHALMIC SURGICAL OCULAR MARKERSMyocure, Inc.1986-10-20
K861535OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNUCooperVision, Inc.1986-05-14

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