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510(k) K823809

Device
CLAVICAL STRAP
Applicant
DANEK MEDICAL, INC.
510(k) number
K823809
Product code
IQJ  
Decision
Substantially Equivalent (SESE)
Decision date
1983-01-14
Date received
1982-12-17
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
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 IQJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K823661CLAVICLE SUPPORTWarm & Form, Orthopedic Materials1982-12-30
K823157CLAVICLE SUPPORTWarm & Form, Orthopedic Materials1982-11-10
K760577RICHARDS CLAVICLE STRAPRichard'S Medical Equip., Inc.1976-10-06

Legacy Summary#

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FDA Review#

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