510(k) K950520

Device
BURR, CORNEAL, BATTERY-POWERED
Applicant
AARON MEDICAL INDUSTRIES
510(k) number
K950520
Product code
HOG  
Decision
Substantially Equivalent (SESE)
Decision date
1995-05-02
Date received
1995-02-06
Regulation
886.4070
Classification name
Burr, Corneal, Battery-powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
J. R SARON
Address
7100 30th Ave. N St. Petersburg FL US 33710 33710

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
K883785GY-RO SAFEGy-Ro Industry, Inc.1989-01-05
K834354OPHTEC RUST RING REMOVERJedmed Instrument Co.1984-03-19

Legacy Summary#

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FDA Review#

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