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510(k) K834354

Device
OPHTEC RUST RING REMOVER
Applicant
JEDMED INSTRUMENT CO.
510(k) number
K834354
Product code
HOG  
Decision
Substantially Equivalent (SESE)
Decision date
1984-03-19
Date received
1983-12-13
Regulation
886.4070
Classification name
Burr, Corneal, Battery-powered
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 HOG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K962989AMOILS EPITHELIAL SCRUBBERS. Percy Amoils1997-01-09
K960261PALLIKARIS BRUSHAlcon Laboratories, Inc.1996-03-11
K950520BURR, CORNEAL, BATTERY-POWEREDAaron Medical Industries1995-05-02
K883785GY-RO SAFEGy-Ro Industry, Inc.1989-01-05

Legacy Summary#

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FDA Review#

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