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510(k) K840372

Device
FLEXIBLE ILLUMINATOR 15
Applicant
SUNCOAST MEDICAL MANUFACTURERS, INC.
510(k) number
K840372
Product code
FTF  
Decision
Substantially Equivalent (SESE)
Decision date
1984-04-24
Date received
1984-01-27
Regulation
878.4580
Classification name
Illuminator, Non-remote
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
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 FTF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K041621LITEPORT LP100 SURGICAL ILLUMINATORMedical Vision Industries, Inc.2004-09-13
K840371FLEXIBLE ILLUMINATOR 5Suncoast Medical Manufacturers, Inc.1984-04-24
K840373FLEXIBLE ILLUMINATOR 10Suncoast Medical Manufacturers, Inc.1984-04-24

Legacy Summary#

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FDA Review#

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