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510(k) K041621

Device
LITEPORT LP100 SURGICAL ILLUMINATOR
Applicant
Medical Vision Industries, Inc.
510(k) number
K041621
Product code
FTF
Decision
Substantially Equivalent (SESE)
Decision date
2004-09-13
Date received
2004-06-16
Regulation
878.4580
Classification name
Illuminator, Non-Remote
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
DAVID SCHLERF
Address
200 Gregory Ln. Suite C-100 Pleasant Hill CA US 94523 94523

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FTF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K840371FLEXIBLE ILLUMINATOR 5Suncoast Medical Manufacturers, Inc.1984-04-24
K840372FLEXIBLE ILLUMINATOR 15Suncoast Medical Manufacturers, Inc.1984-04-24
K840373FLEXIBLE ILLUMINATOR 10Suncoast Medical Manufacturers, Inc.1984-04-24