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510(k) K823157

Device
CLAVICLE SUPPORT
Applicant
WARM & FORM, ORTHOPEDIC MATERIALS
510(k) number
K823157
Product code
IQJ  
Decision
Substantially Equivalent (SESE)
Decision date
1982-11-10
Date received
1982-10-25
Regulation
890.3490
Classification name
Splint, Clavicle
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 IQJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K823809CLAVICAL STRAPDanek Medical, Inc.1983-01-14
K823661CLAVICLE SUPPORTWarm & Form, Orthopedic Materials1982-12-30
K760577RICHARDS CLAVICLE STRAPRichard'S Medical Equip., Inc.1976-10-06

Legacy Summary#

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FDA Review#

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