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510(k) K831702

Device
RARE-EARTH INTRA-OCULAR MAGNET
Applicant
MIAMI EYE TECHNOLOGY, INC.
510(k) number
K831702
Product code
HPN  
Decision
Substantially Equivalent (SESE)
Decision date
1983-06-30
Date received
1983-05-25
Regulation
886.4445
Classification name
Magnet, Permanent
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HPN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K905237EYE SEE INSTRUMENTKing Tool, Inc.1991-02-14
K896473H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUREmory University School of Medicine1990-02-09
K880855PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAGRichard James, Inc.1988-04-01
K860960RARE EARTH INTRA-OCULAR MAGNETAmeritek, Inc.1986-03-31

Legacy Summary#

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FDA Review#

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