FDA.reportPublic FDA data

510(k) K801072

Device
STRAITH NASAL SPLINT
Applicant
SURGICAL TECHNOLOGY LABORATORIES, INC.
510(k) number
K801072
Product code
FYI  
Decision
Substantially Equivalent (SESE)
Decision date
1980-06-17
Date received
1980-05-06
Regulation
878.3250
Classification name
Appliance, Facial Fracture, External
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
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 FYI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K871073OMEGA BIVALVE NASAL SPLINTSOmega Silicone, Inc.1987-05-11
K821178ETHICON EXTERNAL FIXATION WIREETHICON, Inc.1983-06-11
K792106CONPHAR O.R. HEAD COVER-STERILEConphar, Inc.1979-11-05

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