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510(k) K820051

Device
OBUS FORME ORTHOPEDIC BRACE, UPRIGHT
Applicant
OBUS FORME, LTD.
510(k) number
K820051
Product code
IQE  
Decision
Substantially Equivalent (SESE)
Decision date
1982-01-29
Date received
1982-01-08
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
4221 Richmond Rd., NW Walker MI US 49534 49534

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
K812719PROSANA BELTBandwagon, Inc.1981-10-06
K810450TRUNCAL ORTHOSISFred Sammons, Inc.1981-03-04

Legacy Summary#

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FDA Review#

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