FDA.reportPublic FDA data

510(k) K810450

Device
Truncal Orthosis
Applicant
FRED SAMMONS, INC.
510(k) number
K810450
Product code
IQE
Decision
Substantially Equivalent (SESE)
Decision date
1981-03-04
Date received
1981-02-19
Regulation
890.3490
Classification name
Orthosis, Lumbar
Medical specialty
Physical Medicine
Review panel
Physical Medicine
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 IQE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K821682TRUNCAL ORTHOSISSurgical Appliance Industries, Inc.1982-06-24
K820051OBUS FORME ORTHOPEDIC BRACE, UPRIGHTObus Forme, Ltd.1982-01-29
K812719PROSANA BELTBandwagon, Inc.1981-10-06