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510(k) K861535

Device
OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU
Applicant
COOPERVISION, INC.
510(k) number
K861535
Product code
HMR  
Decision
Substantially Equivalent (SESE)
Decision date
1986-05-14
Date received
1986-04-24
Regulation
886.4570
Classification name
Marker, Ocular
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL J ANDREWS
Address
Coopervision Cilco 3190 160th Ave. SE Bellevue WA US 98008 98008

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K925606OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERSChiron Vision Corp.1994-08-29
K872747LASER CENTERING DEVICEInnomed Corp.1987-09-04
K863663OPHTHALMIC SURGICAL OCULAR MARKERSMyocure, Inc.1986-10-20

Legacy Summary#

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FDA Review#

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