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510(k) K880855

Device
PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG
Applicant
RICHARD JAMES, INC.
510(k) number
K880855
Product code
HPN  
Decision
Substantially Equivalent (SESE)
Decision date
1988-04-01
Date received
1988-03-01
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#

Contact
WAYNE A RICHARD
Address
P.O. Box 309 Lynnfield MA US 01940 01940

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
K860960RARE EARTH INTRA-OCULAR MAGNETAmeritek, Inc.1986-03-31
K831702RARE-EARTH INTRA-OCULAR MAGNETMiami Eye Technology, Inc.1983-06-30

Legacy Summary#

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FDA Review#

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