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510(k) K811297

Device
CERVICAL SUPPORT
Applicant
ORTHOMEDICS
510(k) number
K811297
Product code
IQF  
Decision
Substantially Equivalent (SESE)
Decision date
1981-05-27
Date received
1981-05-11
Regulation
890.3490
Classification name
Orthosis, Cervical-thoracic, Rigid
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 IQF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K832741JASON CERVICAL ORTHOSISOrthomedics1983-09-20
K812342ZEE EXTRICATION DEVICEZee Medical Products Co., Inc.1981-09-21
K810555SCOLIOSIS ORTHOTIC SYSTEMOrthomedics1981-03-13
K791350POPE AMBULATORY HALO VESTHospital Products Co.1979-08-03
K781761KENDRICK EXTRICATION DEVICEMedi-Ked, Inc.1978-10-27
K780489SPINE BOARDMarullo, Baldwin, Frieden, Gatewood,1978-04-12

Legacy Summary#

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FDA Review#

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