FDA.reportPublic FDA data

510(k) K840371

Device
FLEXIBLE ILLUMINATOR 5
Applicant
SUNCOAST MEDICAL MANUFACTURERS, INC.
510(k) number
K840371
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
K840372FLEXIBLE ILLUMINATOR 15Suncoast Medical Manufacturers, Inc.1984-04-24
K840373FLEXIBLE ILLUMINATOR 10Suncoast Medical Manufacturers, Inc.1984-04-24

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases