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510(k) K812719

Device
PROSANA BELT
Applicant
BANDWAGON, INC.
510(k) number
K812719
Product code
IQE  
Decision
Substantially Equivalent (SESE)
Decision date
1981-10-06
Date received
1981-09-25
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
K810450TRUNCAL ORTHOSISFred Sammons, Inc.1981-03-04

Legacy Summary#

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FDA Review#

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